FDA Device recall Z-0722-2022
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
- FDA Device
- Class II
- terminated
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II recall of Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format by Remel, citing there are lower than expected MICs for some gram negative species.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0722-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-10 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Remel |
| Distribution | US |
Product
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Reason
There are lower than expected MICs for some gram negative species.
Identifiers
| code_info | Product Number MDRGN2F; Lots: 1) B1402A (Expiration 2022/Oct05) 2) B1315A (Expiration 2022/Aug06) 3) B1211 (Expirati…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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FDA Device · Class II · 2026-03-04 · Remel - 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
FDA Device · Class II · 2025-12-03 · Remel - Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
FDA Device · Class II · 2025-08-06 · Remel
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0722-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.