Microbiologics Inc Recall 89513
Description: LYFO Disk
Microbiologics Inc Recall 89513 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0788-2022 |
| Event ID | 89513 |
| Event Description | LYFO Disk |
| Product Type | Devices |
| Distribution | Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio. |
| Quantity | 3 units |
| Recall Reason | LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results. |
| Device Classification | 20220323 |
| Device Code Info | Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016) |
| Center Classification Date | 20220316 |
| Recall Initiation Date | 20150717 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | Letter |
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