CLASS II ONGOING Device recall · Reported 22 Nov 2023 · FDA Enforcement Report
Kwikstik, P. venetum recalled by Microbiologics
Microbiologics is recalling Kwikstik, P. venetum, distributed nationwide in the US. The recall was initiated on 18 Oct 2023 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-0307-2024
- FDA event ID
- 93267
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Oct 2023
- FDA classified
- 15 Nov 2023
- Reported
- 22 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Oct 2023 | Recall initiated by company | |
| 15 Nov 2023 | Classified by FDA | +28 days |
| 22 Nov 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Product as listed by the FDA
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
Questions about this recall
Why was it recalled?
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Which lots are affected?
a) UDI/DI 20845357019169, Lot Numbers: 794-142-2, 794-142-4 b) UDI/DI 30845357019173, Lot Numbers: 794-142-3
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
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.
Other products in this recall event
1 other product · FDA event 93267| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lyfo-disk, P recalled by Microbiologics | Microbiologics | Other | Nationwide |
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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