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.
FDA Recall Z-1743-2019 · Posted None
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Recalling FirmBio-Rad Laboratories, Inc
Recall StatusTerminated
Product CodeJSO
Date Initiated2018-06-08
Date Terminated2020-10-30
Product Quantity3,632 units
Reason for Recall
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
Firm Action
The firm. Bio-Rad laboratories, Inc., issued an "URGENT PRODUCT CORRECTION" letter dated 6/7/2018 to all customers via FedEx on 6/7-8/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
" As already recommended in the package insert, please ensure that exposure of agar plates to light is minimized, both before and during incubation, with the added time restriction of no more than 2 hours during storage, warming, incubation, and reading.
" Do not use agar with a change in color from white to an orange-pinkish shade.
" As recommended in the package insert, if in doubt, confirm the identification of colonies by coagulase test or PASTOREX STAPH-PLUS.
Please feel free to contact Technical Support with any questions or concerns at 1-800-224-6723, option #2 and then #3.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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