API ID 32 C Strips — Class II medical device recall Z-0525-2022
Terminated recall by Biomerieux Inc, reported 2022-02-02, distributed in AZ, IA, KY, NY. Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
| Recall number | Z-0525-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2021-12-20 |
| Classified | 2022-01-25 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2023-09-25 |
| Distributed | AZ, IA, KY, NY |
| Quantity | 462 kits |
| Lot numbers | 1008781060 |
| Model numbers | 32200 |
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 for recall
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0525-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.