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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1,382
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
Related recalls
Same manufacturer · bioMerieux, Inc.
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
Same hazard · organism misidentification
See all →- ModerateLYFO Disk Quality Control Product Recalled for Organism Mislabeling
FDA (Devices) · 2022-03-23
- ModerateLYSO Disk microorganism culture device mislabeled with incorrect strain
FDA (Devices) · 2022-02-16
- ModerateMicrobiologics Recalls KWIK-STIK Microorganism Reference Material Due to Organism Mislabeling
FDA (Devices) · 2022-02-16
Similar recalls
- HighBioMerieux PREVI Isola System Recalled for Potential False Negative Results
FDA (Devices) · 2014-03-19
- ModerateDiagnostic Test Kit Recalled Due to Exceeded Storage Conditions
FDA (Devices) · 2023-01-11
- ModerateBioMerieux BacT/ALERT Combo Modules Recalled for Software Mislabeling
FDA (Devices) · 2012-11-28
- HighAPI ID 32 C Diagnostic Strips Recalled Due to Thermoforming Defect
FDA (Devices) · 2022-02-02
- ModerateBioMerieux B.40 Software Update Recalled for Patient Mislabeling
FDA (Devices) · 2012-11-28
- ModerateBioMérieux BacT/ALERT 3D 60 Recalled for Software Mislabeling Error
FDA (Devices) · 2012-11-28