Z-1743-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- June 8, 2018
- Termination Date
- October 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,632 units
Product Description
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.
Reason for Recall
Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
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.
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.