KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
FDA device recall Z-2124-2025 · posted 2025-07-17 · Open, Classified
Recall details
- Recalling firm
- Microbiologics Inc
- 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.
- Action taken
- On June 17. 2025, the firm began notifying affected customers via "Urgent Medical Device Recall" letters delivered through email. Customers were instructed to review lab procedures to understand how the information may affect usage; use or discard product depending on lab procedures. Complete and return the response form to recall@microbiologics.com. If product was further distributed or transferred to other facilities or customers, they should also be notified. Customers may contact Microbiologics if a replacement kit is needed. If you have any questions or concerns, contact Recall Support team at 320.229.7080 or recall@microbiologics.com. Collect calls may be made.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JTR
- Quantity affected
- 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.
- Date initiated
- 2025-06-17
- Date posted
- 2025-07-17
- Location
- Saint Cloud, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) | Micro-Bio-Logics | 1986-04-04 |