CLASS II ONGOING Device recall · Reported 23 Jul 2025 · FDA Enforcement Report
Kwik-stik and Lyfo Disk, quality control kit for culture media recalled
Microbiologics is recalling Kwik-stik and Lyfo Disk, quality control kit for culture media, distributed in Ohio, Utah. The recall was initiated on 17 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2124-2025
- FDA event ID
- 97096
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2025
- FDA classified
- 17 Jul 2025
- Reported
- 23 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Bacterial Contamination
- Device type
- Other Medical Devices
Timeline
| 17 Jun 2025 | Recall initiated by company | |
| 17 Jul 2025 | Classified by FDA | +30 days |
| 23 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Where it was distributed
US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 805-234-4, 805-234-5 UDI: (0805K) 30845357019531, (0805L) 10845357019544
Where was it sold?
US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Microbiologics
All 66| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lyfo Disk, Campylobacter jejuni subsp recalled by Microbiologics | Microbiologics | Other Bacterial Contamination | Nationwide |
| Device | CLASS II | Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics | Microbiologics | Other Bacterial Contamination | Nationwide |
| Device | CLASS II | Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics | Microbiologics | Other Bacterial Contamination | Nationwide |
| Device | CLASS II | Kwik-stik, Quality control kit for culture media recalled | Microbiologics | Packaging Defects | MN |
| Device | CLASS II | Lyfo-disk, M. Canis Derived from Atcc 36299, packaged as recalled | Microbiologics | Device Malfunction | Nationwide |
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