Z-0722-2022 Class II Terminated
FDA device recall Z-0722-2022 was initiated by Remel Inc on Jan 10, 2022 and is designated Class II. Reason for recall: There are lower than expected MICs for some gram negative species. The recall status is terminated (terminated Jul 24, 2026). Affected quantity: 1210 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 16, 2022
- Initiation Date
- Jan 10, 2022
- Termination Date
- Jul 24, 2026
- 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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0722-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026