CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report

Kwik-stik, Quality control kit for culture media, sold as recalled

Microbiologics is recalling Kwik-stik, Quality control kit for culture media, sold as: a. Kwik-stik Enterococcus, distributed nationwide in the US. The recall was initiated on 6 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa. Catalog Number 0959P, UDI: 20845357023210, Lot Number (Expiration Date): 959-74-2 (10/08/2014), 959-74-3 (10/08/2014), 959-74-7 (10/08/2014), 959-75-4 (04/22/2015), 959-75-8 (04/22/2015), 959-75-9 (04/22/2015), 959-75-14 (04/22/2015), 959-76-1 (07/08/2015), 959-77-3 (10/21/2015); b. Catalog Number 0959K, UDI: 30845357023224, Lot Number (Expiration Date): 959-74-4 (10/08/2014), 959-74-6 (10/08/2014), 959-74-8 (10/08/2014), 959-75-1 (04/22/2015), 959-75-8 (04/22/2015), 959-75-12 (04/22/2015), and 959-77-1 (10/21/2015)

Quantity recalled1,873 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-0712-2022
FDA event ID: 89451
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 6 Oct 2014
FDA classified: 3 Mar 2022
Reported: 9 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Oct 2014	Recall initiated by company
3 Mar 2022	Classified by FDA	+2705 days
9 Mar 2022	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

This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

Product as listed by the FDA

KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

Which lots are affected?

a. Catalog Number 0959P, UDI: 20845357023210, Lot Number (Expiration Date): 959-74-2 (10/08/2014), 959-74-3 (10/08/2014), 959-74-7 (10/08/2014), 959-75-4 (04/22/2015), 959-75-8 (04/22/2015), 959-75-9 (04/22/2015), 959-75-14 (04/22/2015), 959-76-1 (07/08/2015), 959-77-3 (10/21/2015); b. Catalog Number 0959K, UDI: 30845357023224, Lot Number (Expiration Date): 959-74-4 (10/08/2014), 959-74-6 (10/08/2014), 959-74-8 (10/08/2014), 959-75-1 (04/22/2015), 959-75-8 (04/22/2015), 959-75-12 (04/22/2015), and 959-77-1 (10/21/2015)

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 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

2 other products · FDA event 89451

This product is part of a recall event; the main page for the event is Kwik-stik, Quality control kit for culture media, sold as recalled.

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022	CLASS II	Kwik-stik, Quality control kit for culture media, sold as recalled	Microbiologics	Other	Nationwide
9 Mar 2022	CLASS II	Lyfo-disk, Quality control kit for culture media, sold as recalled	Microbiologics	Other	Nationwide

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	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
6 Aug 2025Device	CLASS II	Lyfo-disk, M. Canis Derived from Atcc 36299, packaged as recalled	Microbiologics	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,884

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Palacos R pro recalled by Heraeus Medical GmbH (Dental	Heraeus Medical GmbH (Dental Division)	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide