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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82761

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bio-Rad Laboratories, 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

2 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 2

MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

Z-1742-2019
Recall number
Z-1742-2019
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bio-Rad Laboratories, Inc
Quantity
5,212 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

Code information

Lot numbers 64179161, exp. 6/8/2018; 64180987, exp. 6/15/2018; 64182474, exp. 6/23/2018; 64184888, exp. 6/30/2018; 64187551, exp. 7/6/2018; 64189117, exp. 7/13/2018; 64190797, exp. 7/22/2018; and 64192125, exp. 8/3/2018.

Distribution pattern

US Nationwide Distribution to: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico.

device · product 2 of 2

MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

Z-1743-2019
Recall number
Z-1743-2019
Initiated
June 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bio-Rad Laboratories, Inc
Quantity
3,632 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

Code information

Lot numbers 64177778, exp. 6/10/2018; 64179165, exp. 6/17/2018; 64182547, exp. 7/3/2018; 64184389, exp. 7/8/2018; 64187554, exp. 7/22/2018; 64189124, exp. 7/23/2018; and 64190805, exp. 7/31/2018.

Distribution pattern

US Nationwide Distribution to: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico.