Recall Z-2124-2025
Microbiologics Inc · initiated June 17, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Codes / lots: Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-2124-2025
- Initiated
- June 17, 2025
- Posted by FDA
- July 17, 2025
- Product code
- JTR – Kit, Quality Control For Culture Media
- 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.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN