CLASS II Device recall · Reported 24 Nov 2021 · FDA Enforcement Report

API 50 CH recalled by bioMerieux

bioMerieux is recalling API 50 CH, distributed in New York, South Dakota, Wisconsin. The recall was initiated on 30 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230

Quantity recalled1382 kits

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-0243-2022
FDA event ID: 88844
Recalling firm: bioMerieux, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 30 Sep 2021
FDA classified: 17 Nov 2021
Reported: 24 Nov 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Sep 2021	Recall initiated by company
17 Nov 2021	Classified by FDA	+48 days
24 Nov 2021	Published in enforcement report	+7 days

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

Reason for recall

There is potential to provide an incorrect organism identification.

Product as listed by the FDA

API 50 CH, Model 50300

Where it was distributed

Distribution in WI, NY, and SD

New York South Dakota Wisconsin

Questions about this recall

Is API 50 CH recalled?

Yes. bioMerieux recalled API 50 CH on 30 Sep 2021. The recall is Class II and its status is Terminated. Recall number Z-0243-2022.

Why was it recalled?

There is potential to provide an incorrect organism identification.

Which lots are affected?

Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230

Where was it sold?

Distribution in WI, NY, and SD

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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