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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83406

19 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 17, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton Dickinson & Co.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

19 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 19

Kit BD Max Check-Points CPO IVD EU; Catalog # 278102

Z-2321-2019
Recall number
Z-2321-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
130 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9114645; UDI (GTIN, DI+PI): (01)00180002781029 (17)200719(10)9114645(30)1

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 2 of 19

Kit BD Max Cdiff EU; Catalog # 442555

Z-2322-2019
Recall number
Z-2322-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9127912 ; UDI (GTIN, DI+PI): (01)00382904425555 (17)201114(10)9127912(30)1

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 3 of 19

Kit BD Max ExK DNA 1 USA; Catalog # 442817

Z-2323-2019
Recall number
Z-2323-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
115 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9085666; UDI (GTIN, DI+PI): (01)00382904428174 (17)201024(10)9085666(30)1; Exp: 10/24/2020 Lot #9106886; UDI (GTIN, DI+PI): (01)00382904428174 (17)201107(10)9106886(30)11; Exp: 11/7/2020 Lot #9127935; UDI (GTIN, DI+PI): (01)00382904428174 (17)201130(10)9127935(30)11; Exp: 11/30/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 4 of 19

Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818

Z-2324-2019
Recall number
Z-2324-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
447 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot# 9085668; UDI (GTIN, DI+PI):(01)00382904428181 (17)201024(10)9085668(30)1; Exp:10/24/2020 Lot # 9106887; UDI (GTIN, DI+PI):(01)00382904428181 (17)201107(10)9106887(30)1; Exp: 11/7/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 5 of 19

Kit BD Max ExK DNA 2 USA; Catalog # 442819

Z-2325-2019
Recall number
Z-2325-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot #9114654; UDI (GTIN, DI+PI):(01)00382904428198 (17)201107(10)9114654(30)1; Exp: 11/7/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 6 of 19

Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820

Z-2326-2019
Recall number
Z-2326-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9114655; UDI (GTIN, DI+PI): (01)00382904428204 (17)201107(10)9114655(30)1; Exp:11/7/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 7 of 19

Kit BD Max ExK TNA 2; Catalog # 442825

Z-2327-2019
Recall number
Z-2327-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
86 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9106876; UDI (GTIN, DI+PI): (01)00382904428259 (17)201107(10)9106876(30)1; Exp: 11/7/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 8 of 19

Kit BD Max MRSA; Catalog # 442953

Z-2328-2019
Recall number
Z-2328-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
176 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9071522; UDI (GTIN, DI+PI): (01)00382904429539 (17)191219(10)9071522(30)1; Exp :12/19/2019

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 9 of 19

Kit BD Max Enteric Parasite Panel EU; Catalog # 442960

Z-2329-2019
Recall number
Z-2329-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
355 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9106889; UDI (GTIN, DI+PI):(01)00382904429607 (17)201115(10)9106889(30)1; Exp: 11/15/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 10 of 19

Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963

Z-2330-2019
Recall number
Z-2330-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
994 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9085672; UDI (GTIN, DI+PI):(01)00382904429638 (17)201011(10)9085672(30)1; Exp:10/11/2020 Lot # 9085673; UDI (GTIN, DI+PI):(01)00382904429638 (17)201011(10)9085673(30)1; Exp:10/11/2020 Lot # 9106961; UDI (GTIN, DI+PI): (01)00382904429638 (17)201011(10)9106961(30)1; Exp:10/11/2020 Lot # 9106962; UDI (GTIN, DI+PI): (01)00382904429638 (17)201102(10)9106962(30)1; Exp:11/2/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 11 of 19

Kit BD Max CT/GC/TV; Catalog # 442970

Z-2331-2019
Recall number
Z-2331-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
913 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9080876; UDI (GTIN, DI+PI): (01)00382904429706 (17)200414(10)9080876(30)1; Exp: 4/14/2020 Lot #9092733; UDI (GTIN, DI+PI): (01)00382904429706 (17)200414(10)9092733(30)1; Exp: 4/14/2020 Lot #9092734; UDI (GTIN, DI+PI): (01)00382904429706 (17)200512(10)9092734(30)1; Exp: 5/12/2020 Lot #9106875; UDI (GTIN, DI+PI): (01)00382904429706 (17)200512(10)9106875(30)1; Exp: 5/12/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 12 of 19

Kit BD Max StaphSR; Catalog # 443418

Z-2332-2019
Recall number
Z-2332-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
283 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9086668; ; UDI (GTIN, DI+PI) : (01)00382904434199 (17)200902(10)9086668(30)1; Exp :9/2/2020 Lot # 9092724; UDI (GTIN, DI+PI) :(01)00382904434199 (17)200902(10)9092724(30)1; Exp: 9/2/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 13 of 19

Kit BD Max StaphSR; Catalog # 443419

Z-2333-2019
Recall number
Z-2333-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
207 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9086668; ; UDI (GTIN, DI+PI) : (01)00382904434199 (17)200902(10)9086668(30)1; Exp :9/2/2020 Lot # 9092724; UDI (GTIN, DI+PI) :(01)00382904434199 (17)200902(10)9092724(30)1; Exp: 9/2/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 14 of 19

Kit BD Max MRSA XT; Catalog # 443461

Z-2334-2019
Recall number
Z-2334-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
61 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9106890; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200828(10)9106890(30)1; Exp :8/28/2020 Lot # 9106891; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200909(10)9106891(30)1; Exp :9/9/2020 Lot # 9114657; UDI (GTIN, DI+PI) :(01)00382904434618 (17)200922(10)9114657(30)1; Exp : 9/22/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 15 of 19

Kit BD Max GC RT PCR Assay; Catalog # 443486

Z-2335-2019
Recall number
Z-2335-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9092736; UDI (GTIN, DI+PI): (01)00382904434861 (17)200425(10)9092736(30)1; Exp : 4/25/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 16 of 19

Kit BD Max Vaginal Panel; Catalog # 443712

Z-2336-2019
Recall number
Z-2336-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
666 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9092737; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9092737(30)1; Exp : 3/21/2020 Lot # 9092738; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9092738(30)1; Exp :3/21/2020 Lot # 9127920; UDI (GTIN, DI+PI): (01)00382904437121 (17)200321(10)9127920(30)1; Exp : 3/21/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 17 of 19

Kit BD Max Enteric Viral Panel RUO; Catalog # 443715

Z-2337-2019
Recall number
Z-2337-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
27units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9114647; UDI (GTIN, DI+PI): (01)00382904437152 (17)201107(10)9114647(30)1; Exp: 11/7/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 18 of 19

Kit EXT Enteric Bacterial Panel; Catalog # 443812

Z-2338-2019
Recall number
Z-2338-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
715 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9114557; UDI (GTIN, DI+PI): (01)00382904438128 (17)201107(10)9114557(30)1; Exp: 11/7/2020 Lot # 9126778; UDI (GTIN, DI+PI): (01)00382904438128 (17)201117(10)9126778(30)1; Exp: 11/17/2020 Lot # 9129979; UDI (GTIN, DI+PI): (01)00382904438128 (17)201122(10)9129979(30)1; Exp: 11/22/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan

device · product 19 of 19

Kit BD Max Enteric Viral Panel EU Catalog # 443985

Z-2339-2019
Recall number
Z-2339-2019
Initiated
July 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
469 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.

Code information

Lot # 9085674; UDI (GTIN, DI+PI): (01)00382904439859 (17)201101(10)9085674(30)1; Exp: 11/1/2020 Lot # 9107980; UDI (GTIN, DI+PI): (01)00382904439859 (17)201107(10)9107980(30)1; Exp: 11/7/2020

Distribution pattern

AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV Worldwide: Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, Taiwan