Recall archive / FDA device enforcement
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identifica... — FDA record Z-0525-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 20, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It uses miniaturized tests as well as a specially adapted database. After manual inoculation of the strip, reading can be performed either automatically or manually and the identification is obtained using an identification software.
- Reason
- Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
- Classification
- Class II
- Recalling firm
- Biomerieux Inc
- Quantity
- 462 kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0525-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. 32200; Lot 1008781060. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 2, 2022
- Recall initiation date
- Dec 20, 2021
- Center classification date
- Jan 25, 2022
- Termination date
- Sep 25, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.