Z-0722-2022 Class II Ongoing

Recalled by Remel Inc — Lenexa, KS

Recall Details

Product Type
Devices
Report Date
March 16, 2022
Initiation Date
January 10, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1210 devices

Product Description

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Reason for Recall

There are lower than expected MICs for some gram negative species.

Distribution Pattern

Distribution throughout the United States.

Code Information

Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expiration 2022/May24) 4) B1161A (Expiration 2022/Apr19 5) B0361 (Expiration 2021/Aug31) 6) B0164B (Expiration 2021/Apr16)