Device 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.
Z-0525-2022
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 89329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 462 kits
- Official record key
device-enforcement:Z-0525-2022
Official wording
Reason: Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Code information: Model No. 32200; Lot 1008781060.
Distribution pattern: US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
Derived failure modes
-
Unknown
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.