Reported Mar 16, 2022 · Terminated
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Remel Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Remel Inc · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519
Is this the product you have?
- Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 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) - Amount recalled
- 1210 devices
Why it was recalled
There are lower than expected MICs for some gram negative species.
This product could cause temporary or reversible health problems — stop using it.
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