Biomerieux Inc Recall 89329
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.
Biomerieux Inc Recall 89329 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0525-2022 |
| Event ID | 89329 |
| Event 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. |
| Product Type | Devices |
| Distribution | US (Domestic) Distribution to states of: AZ, IA, KY, and NY. |
| Quantity | 462 kits |
| Recall Reason | Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. |
| Device Classification | 20220202 |
| Device Code Info | Model No. 32200; Lot 1008781060. |
| Center Classification Date | 20220125 |
| Recall Initiation Date | 20211220 |
| Recalling Firm | Biomerieux Inc |
| Initial Notification | Letter |
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