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