API 50 CH, Model 50300 recallZ-0243-2022 · bioMerieux, Inc. · initiated Sep 30, 2021

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from bioMerieux, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is potential to provide an incorrect organism identification.

FDA root cause category: Material/Component Contamination

What the company is doing

Notification letters were issued to customers via FedEx Priority Overnight mail during the week of October 4, 2021. Customers are asked to do the following: -Discontinue use of and discard any remaining inventory of lot 1008679230. -For tests previously performed using API 50 CH Ref. 50300 lot# 1008679230, we are asking you to identify any possible incorrect identification test result due to a false positive reaction of test 34, analyze the related risks and to determine appropriate actions, if relevant. -Complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. -Distribute this information to all appropriate personnel in the laboratory, retain a copy in your files. -Contact your local bioMrieux representative for product compensation. Consignees will perform destruction activities at their site.

Recall details

Recall number: Z-0243-2022
Status: Terminated
Initiated by the company: Sep 30, 2021
Recalling firm: bioMerieux, Inc.
Quantity: 1382 kits
Product code: JSC
Distribution: Distribution in WI, NY, and SD

Product description

API 50 CH, Model 50300

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

API® 50 CH
Biomerieux SA · CULTURE MEDIA, GENERAL NUTRIENT BROTH
1 recall1 report

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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