Z-1743-2019 Class II Terminated
FDA device recall Z-1743-2019 was initiated by Bio-Rad Laboratories, Inc on June 8, 2018 and is designated Class II. Reason for recall: Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. The recall status is terminated (terminated October 30, 2020). Affected quantity: 3,632 units.
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.