FDAClass IIMarch 16, 2022

Thermo Scientific Sensititre Gram Negative recall

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Why was Thermo Scientific Sensititre Gram Negative recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Recalling firm
Remel Inc
Quantity
1210 devices
Distribution
Distribution throughout the United States.
Recall date
March 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls