Microbiologics Inc: Device Recall

Recall #Z-2124-2025 · 06/17/2025

Class II: Risk

Recall Details

Recall Number: Z-2124-2025
Classification: Class II
Product Type: Device
Recalling Firm: Microbiologics Inc
Status: Ongoing
Date Initiated: 06/17/2025
Location: Saint Cloud, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21 total

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.

Product Description

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

Distribution Pattern

US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.

Other Recalls by Microbiologics Inc

Class II: Risk 12/02/2025

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 12/02/2025

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 12/02/2025

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 11/13/2025

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Class II: Risk 06/27/2025

KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

View all recalls by Microbiologics Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.