Microbiologics Inc recalls KWIK-STIK and LYFO DISK

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2124-2025
• FDA 510(k) clearance · K861022The device's official FDA premarket clearance record
• FDA device classification · JTROfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2480The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Microbiologics IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.