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

Lot, batch or date codesCatalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)

Quantity recalled10 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-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: Labeling Errors
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.

Nationwide

Questions about this recall

Is Kwik-stik(TM), Quality control kit for culture media, sold as: Kwik-stik(TM) Enterococcus recalled?

Yes. Microbiologics recalled Kwik-stik(TM), Quality control kit for culture media, sold as: Kwik-stik(TM) Enterococcus on 25 Mar 2013. The recall is Class III and its status is Terminated. Recall number Z-0641-2022.

Why was it recalled?

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 21 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
31 Dec 2025Device	CLASS II	Lyfo Disk, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Device Malfunction	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Device Malfunction	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Device Malfunction	Nationwide
10 Dec 2025Device	CLASS II	Kwik-stik, Quality control kit for culture media recalled	Microbiologics	Packaging Defects	Nationwide
6 Aug 2025Device	CLASS II	Lyfo-disk, M recalled by Microbiologics	Microbiologics	Packaging Defects	Nationwide

Other Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide