Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0788-2022 — LYFO Disk

U.S. FDA — Device Enforcement · United States · 2015-07-17 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0788-2022
Date of alert
2015-07-17
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Microbiologics Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10845357023930
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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