KWIK-STIK and LYFO DISK, quality control kit for culture… recallZ-2124-2025 · Microbiologics Inc · initiated Jun 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2124-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 17, 2025
- Posted by the FDA
- Jul 17, 2025
- Recalling firm
- Microbiologics Inc
- Quantity
- 21 total
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
Product description
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Code information (models, lots, serial numbers)
Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- KWIK-STIK™ 0805UMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
- LYFO DISK™ 0805LMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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