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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87486

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

Open FDA event record

Event summary

Timeline bucket
September 04, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Beckman Coulter Inc.

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

4 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 4

MicroScan WalkAway-40 plus Instrument

Z-1370-2021
Recall number
Z-1370-2021
Initiated
September 04, 2019
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
16 systems

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Quality Control (QC) failure

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

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Code information

Catalog Number: B1018-283 UDI Code: 1509959065866 Serial Numbers: 34010001 34010002 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016

Distribution pattern

U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen.

device · product 2 of 4

MicroScan WalkAway-96 plus Instrument

Z-1371-2021
Recall number
Z-1371-2021
Initiated
September 04, 2019
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
12 systems

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Quality Control (QC) failure

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

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Code information

Catalog Number: B1018-284 UDI Code: 15099590658687 Serial Numbers: 39610001 39610002 39610003 39610004 39610005 39610006 39610007 39610008 39610009 39610010 39610011 39610012

Distribution pattern

U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen.

device · product 3 of 4

MicroScan WalkAway-40 plus Reconditioned Instrument

Z-1372-2021
Recall number
Z-1372-2021
Initiated
September 04, 2019
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
6 systems

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Quality Control (QC) failure

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

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Code information

Catalog Number: B1018-340R UDI Code: 15099590684112 Serial Numbers: 34020035 34020224 34030054 3407179 3407459 3407532

Distribution pattern

U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen.

device · product 4 of 4

MicroScan WalkAway-96 plus Reconditioned Instrument

Z-1373-2021
Recall number
Z-1373-2021
Initiated
September 04, 2019
Classification
Class II
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
9 systems

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Quality Control (QC) failure

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

Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

Code information

Catalog Number: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442

Distribution pattern

U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen.