Recall Z-0525-2022— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2021-12-20, terminated 2023-09-25. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-20
- Terminated
- 2023-09-25
- Firm location
- Hazelwood, MO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.