CLASS II Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

Thermo Scientific Sensititre Gram Negative Susceptibility recalled

Remel is recalling Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format, distributed nationwide in the US. The recall was initiated on 10 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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)

Quantity recalled1210 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0722-2022
FDA event ID: 89416
Recalling firm: Remel, Lenexa, KS
Classification: Class II
Status: Terminated
Recall initiated: 10 Jan 2022
FDA classified: 4 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Jan 2022	Recall initiated by company
4 Mar 2022	Classified by FDA	+53 days
16 Mar 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

Where it was distributed

Distribution throughout the United States.

Nationwide

Questions about this recall

Is Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format recalled?

Yes. Remel recalled Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format on 10 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0722-2022.

Why was it recalled?

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

Which lots 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)

Where was it sold?

Distribution throughout the United States.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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