KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
FDA Recall #Z-2124-2025 — Class II — June 17, 2025
Product Description
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
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.
Recalling Firm
Microbiologics Inc — Saint Cloud, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21 total
Distribution
US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
Code Information
Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.