KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
FDA Recall Z-2124-2025 · Posted 2025-07-17
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Recalling FirmMicrobiologics Inc
Recall StatusOpen, Classified
Product CodeJTR
Date Initiated2025-06-17
Product Quantity21 total
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.
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 [email protected]. 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 [email protected]. Collect calls may be made.
Root Cause
Under Investigation by firm
Distribution Pattern
US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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