Class III — Microbiologics Inc
| Recalling firm | Microbiologics, Inc. |
|---|---|
| Registered facility | Microbiologics, Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Completed |
| 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. |
| Product | LYFO Disk |
| Quantity | 3 units |
| Distribution | Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio. |
| Initiated | 2015-07-17 |
| Classified | 2022-03-16 |
| Recall number | Z-0788-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Microbiologics Inc (Z-0788-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89513/
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