Device product
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Z-0722-2022
Product summary
- Firm
- Remel Inc
- Event
- Event 89416
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1210 devices
- Official record key
device-enforcement:Z-0722-2022
Official wording
Reason: There are lower than expected MICs for some gram negative species.
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)
Distribution pattern: Distribution throughout the United States.
Derived failure modes
-
Unknown
There are lower than expected MICs for some gram negative species.