Z-0525-2022 Class II Terminated
FDA device recall Z-0525-2022 was initiated by Biomerieux Inc on Dec 20, 2021 and is designated Class II. Reason for recall: Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. The recall status is terminated (terminated Sep 25, 2023). Affected quantity: 462 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 2, 2022
- Initiation Date
- Dec 20, 2021
- Termination Date
- Sep 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 462 kits
Product 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 for Recall
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Distribution Pattern
US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
Code Information
Model No. 32200; Lot 1008781060.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0525-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026