API 50 CH Diagnostic Test Kit Recall: Potential Organism Misidentification
BioMerieux is recalling 1,382 API 50 CH diagnostic test kits because they may provide incorrect organism identification results, potentially leading to misdiagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device classified as a risk-of-harm product, as incorrect organism identification could lead to patient misdiagnosis and inappropriate treatment. The source text does not report any illnesses or injuries, and per the rubric, risk-of-harm products without reported injury receive a High severity score.
Plain-English summary
BioMerieux, Inc. is recalling 1,382 units of the API 50 CH microbiological identification test kit (Model 50300) due to a potential defect that could provide incorrect organism identification.
The recalled kits have Lot number 1008679230 and were distributed in Wisconsin, New York, and South Dakota. The potential error in organism identification could result in misdiagnosis and inappropriate treatment decisions for patients whose samples are tested using affected kits.
Healthcare facilities and laboratory personnel that have received affected units should immediately discontinue use and review testing results from the recalled lot. Contact bioMerieux, Inc. for guidance on handling affected kits.
The recalled product
- Product
- API 50 CH, Model 50300
- Manufacturer
- bioMerieux, Inc.
- Hazard
- organism-misidentification
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model 50300
- Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230
Distribution
Distributed in 3 states:
- NY
- SD
- WI
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