Recall Z-2124-2025 ยท JTR Kit, Quality Control For Culture Media
Microbiologics Inc
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
| Date | Jul 17, 2025 (initiated Jun 17, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861022 | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS Micro-Bio-Logics, Apr 4, 1986 |