Device product
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Z-2124-2025
Product summary
- Event
- Event 97096
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21 total
- Official record key
device-enforcement:Z-2124-2025
Official wording
Reason: 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.
Code information: Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544
Distribution pattern: US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
Derived failure modes
-
Unknown
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.