CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report

MRSASelect II, IVD recalled by Bio-Rad Laboratories

Bio-Rad Laboratories is recalling MRSASelect II, IVD, distributed nationwide in the US. The recall was initiated on 8 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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.

Quantity recalled3,632 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1743-2019
FDA event ID: 82761
Recalling firm: Bio-Rad Laboratories, Redmond, WA
Classification: Class II
Status: Terminated
Recall initiated: 8 Jun 2018
FDA classified: 6 Jun 2019
Reported: 12 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

8 Jun 2018	Recall initiated by company
6 Jun 2019	Classified by FDA	+363 days
12 Jun 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 82761

This product is part of a recall event; the main page for the event is MRSASelect, IVD recalled by Bio-Rad Laboratories.

Reported	Class	Recall	Company	Reason	Where
12 Jun 2019	CLASS II	MRSASelect, IVD recalled by Bio-Rad Laboratories	Bio-Rad Laboratories	Packaging Defects	Nationwide

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