Recall Z-2124-2025— Microbiologics Inc

Name: FDA recall Z-2124-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-17

Class II · Ongoing

Class II FDA medical device recall by Microbiologics Inc, initiated 2025-06-17. It names one FDA 510(k) clearance: K861022. Product: KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L. Reason: Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient..

Recalling firm: Microbiologics Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-06-17
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

KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

Reason for recall

Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.

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