Lower riskMedical device recall · FDA · Published September 30, 2021
Biomerieux API 50 CH Model 50300 Recall: Incorrect Organism Identification Risk
Biomerieux recalls API 50 CH Model 50300 due to potential for incorrect organism identification. Affected units include specific lot numbers. Consumers should contact Biomerieux for details.
“Biomerieux API 50 CH Model 50300 Recall: Incorrect Organism Identification Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61732-biomerieux-api-50-ch-model-50300-recall-incorrect-organism-identification. Based on FDA recall #Z-0243-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0243-2022%22&limit=1).
The FDA announced on September 30, 2021, that bioMerieux, Inc. is recalling API 50 CH, Model 50300 diagnostic kits. The recall addresses the potential to provide incorrect organism identification.
How to tell if you have it
Brand: Biomerieux
Product: API 50 CH, Model 50300
Lot code: 1008679230
UPC: 03573026087401
Quantity: 1382 kits
Distribution: WI, NY, and SD
The hazard
The product has the potential to provide an incorrect organism identification.
Context
GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), and Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026).
How to tell if you have this one
Check for the model number '50300' on the device. Affected units include specific lot numbers: 1008679230. The UDI codes (01)03573026087401 and (17)220330 are also indicators.
Brand
Biomerieux
Product
bioMerieux, Inc. recalls API 50 CH, Model 50300
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for the model number '50300' on the device to confirm if it's affected.
Contact Biomerieux
Reach out to Biomerieux for specific instructions on how to handle affected units.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “Distribution in WI, NY, and SD” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York, South Dakota, Wisconsin.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0243-2022 (September 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0243-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.