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.
Reported: February 2, 2022 Initiated: December 20, 2021 #Z-0525-2022
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.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 462 kits
- Distribution
- US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomerieux Inc. Units affected: 462 kits.
Why was this product recalled? ▼
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 2, 2022. Severity: Moderate. Recall number: Z-0525-2022.
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