FDA Enforcement
Class II
Terminated
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.
Recall: Z-0525-2022
·
Reported February 2, 2022
Enforcement
- Recall Number
- Z-0525-2022
- Event ID
- 89329
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomerieux Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 2, 2022
- Initiation Date
- December 20, 2021
- Classification Date
- January 25, 2022
- Termination Date
- September 25, 2023
- Address
- 595 Anglum Rd, Hazelwood, MO, 63042-2320, United States
Description
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.
Code Info
Model No. 32200; Lot 1008781060.
Distribution
US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
Quantity
462 kits