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Recall Observatory FDA recall evidence

Device product

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

June 08, 2018

Class II

Product summary

Firm
Bio-Rad Laboratories, Inc
Event
Event 82761
Status
Terminated
Classification
Class II
Quantity
3,632 units
Official record key
device-enforcement:Z-1743-2019

Official wording

Reason: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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