CLASS III Device recall · Reported 23 Feb 2022 · FDA Enforcement Report
Kwik-stik(TM), Quality control kit for culture media recalled
Microbiologics is recalling Kwik-stik(TM), Quality control kit for culture media, sold as: Kwik-stik(TM) Enterococcus, distributed nationwide in the US. The recall was initiated on 25 Mar 2013 and the FDA has classified it as Class III.
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-0641-2022
- FDA event ID
- 89479
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Mar 2013
- FDA classified
- 14 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Bacterial Contamination
- Device type
- Other Medical Devices
Timeline
| 25 Mar 2013 | Recall initiated by company | |
| 14 Feb 2022 | Classified by FDA | +3248 days |
| 23 Feb 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
Product as listed by the FDA
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
Questions about this recall
Why was it recalled?
Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
Which lots are affected?
Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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|---|---|---|---|---|---|
| Device | CLASS II | Lyfo Disk, Campylobacter jejuni subsp recalled by Microbiologics | Microbiologics | Other Bacterial Contamination | Nationwide |
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| Device | CLASS II | Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics | Microbiologics | Other Bacterial Contamination | Nationwide |
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