Recall Z-1957-2025
Microbiologics Inc · initiated May 27, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Codes / lots: 01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21
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.
FDA-determined cause: Mixed-up of materials/components
Action taken
On May 27, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were informed of the affected products containing the wrong microorganisms. Customers were instructed to review lab procedures to understand how this information affects their usage, and then to use or discard the product depending on the lab procedures and how the issue affects usage. Distributors of the affected product were instructed to contact end users who have received the affected items.
Details
- Recall number
- Z-1957-2025
- Initiated
- May 27, 2025
- Posted by FDA
- June 11, 2025
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 3 total
- Distribution
- US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN