Z-2124-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 23, 2025
- Initiation Date
- June 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 total
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.
Distribution Pattern
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