Recall Z-0525-2022 ยท JXB Kit, Identification, Yeast
Biomerieux Inc
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.
| Date | Dec 20, 2021 |
| Status | Terminated |
| Reason | Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. |
| Root cause | Employee error |
| Action | The firm, bioMrieux, sent an "URGENT FIELD SAFETY NOTICE," to customers on 01/13/2022 informing customers of the recall and the potential for the shape of the API ID 32 C Reference 32200. Customers are asked to inform their laboratory staff of the recall notification, retain a copy for their files, and forward on the notice to any entity to which the product was further distributed. Biomerieux indicated that customers may use the product if the wells are cylindrically shaped but must stop using and destroy any product displaying the microcupule wells. The firm asks that customers contact bio |
| Quantity | 462 kits |
| Distribution | US (Domestic) Distribution to states of: AZ, IA, KY, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.