Recall Z-0307-2024— Microbiologics Inc

Name: FDA recall Z-0307-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-18

Class II · Ongoing

Class II FDA medical device recall by Microbiologics Inc, initiated 2023-10-18. It names one FDA 510(k) clearance: K861022. Product: KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack). Reason: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus..

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-10-18
Firm location: Saint Cloud, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K861022 — KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics·cleared 1986-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.