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Open, Classified

LYFO-DISK, P. venetum, Catalog number 0794L

FDA Recall Z-0308-2024 · Posted 2023-11-15

Recalling FirmMicrobiologics Inc
Recall StatusOpen, Classified
Product CodeJTR
Date Initiated2023-10-18
Product Quantity3 units

Reason for Recall

A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

Firm Action

Microbiologics issued an Urgent Medical Device Recall notice to its consignees on 10/18/2023 via email. The notice explained the issue and requested that the labs review their procedures to understand who the issue affects its usage, use or discard depending on its procedures, and contact Microbiologics if a replacement kit is needed. For questions or concerns contact the Recall Support team at 1.320.229.7073 or [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics · 1986-04-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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