Recall archive / FDA device enforcement
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L — FDA record Z-2124-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
- 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.
- Classification
- Class II
- Recalling firm
- Microbiologics Inc
- Quantity
- 21 total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2124-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 23, 2025
- Recall initiation date
- Jun 17, 2025
- Center classification date
- Jul 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.