LYFO Disk — Class III medical device recall Z-0788-2022
Completed recall by Microbiologics Inc, reported 2022-03-23, distributed nationwide. LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L,
| Recall number | Z-0788-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2015-07-17 |
| Classified | 2022-03-16 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10845357023930 |
| Lot numbers | 983-40-3 |
| Model numbers | 0983L |
Product
LYFO Disk
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0788-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.