FDA-Device2025-06-18Class II
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Microbiologics Inc
Hazard
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.
Sold states
US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
Affected count
3 total
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1957-2025Don't want to check this manually?
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