FDA-Device2025-07-23Class II
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Microbiologics Inc
Hazard
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.
Sold states
US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
Affected count
21 total
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2124-2025Don't want to check this manually?
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