FDA Device recall Z-0525-2022
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts
- FDA Device
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts by Biomerieux, citing risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0525-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-20 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | AZ, IA, KY, NY |
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.
Identifiers
| code_info | Model No. 32200; Lot 1008781060. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0525-2022%22
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