CLASS III Device recall · Reported 16 Feb 2022 · FDA Enforcement Report

Kwik-stik(TM) Clostridium perfringens derived from Atcc(R) 13124(TM) recalled

Microbiologics is recalling Kwik-stik(TM) Clostridium perfringens derived from Atcc(R) 13124(TM). The recall was initiated on 8 Oct 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesCatalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213

Quantity recalled187 units

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-0581-2022
FDA event ID: 89386
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class III
Status: Terminated
Recall initiated: 8 Oct 2020
FDA classified: 8 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Bacterial Contamination
Device type: Other Medical Devices

Timeline

8 Oct 2020	Recall initiated by company
8 Feb 2022	Classified by FDA	+488 days
16 Feb 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.

Product as listed by the FDA

KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

Where it was distributed

US distribution to . International distribution to Austria, Botswana, Brazil, Canada, China, Colombia, Finland, France, Germany, Guatemala, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mauritius, Netherlands, Norway, Oman, Peru, Poland, Romania, South Africa, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213

Where was it sold?

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.

More recalls from Microbiologics

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31 Dec 2025Device	CLASS II	Lyfo Disk, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
10 Dec 2025Device	CLASS II	Kwik-stik, Quality control kit for culture media recalled	Microbiologics	Packaging Defects	MN
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