Microbiologics Inc: Device Recall

Recall #Z-1957-2025 · 05/27/2025

Class II: Risk

Recall Details

Recall Number: Z-1957-2025
Classification: Class II
Product Type: Device
Recalling Firm: Microbiologics Inc
Status: Ongoing
Date Initiated: 05/27/2025
Location: Saint Cloud, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 total

Reason for Recall

Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

Product Description

KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493

Distribution Pattern

US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.

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.