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

Kwik-stik(TM), Streptococcus pneumoniae derived recalled

Microbiologics is recalling Kwik-stik(TM), Streptococcus pneumoniae derived from Atcc(R) 49619(TM), packaged as, distributed nationwide in the US. The recall was initiated on 1 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa. Catalog Number: 0947P; Lot Number: 947-126-2, 947-126-4; UDI: 20845357022947. b. Catalog Number: 0947K; Lot Number: 947-126-3; UDI: 30845357022951

Quantity recalled271 units total

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-0582-2022
FDA event ID: 89391
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 1 Oct 2020
FDA classified: 8 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: E. coli
Device type: Other Medical Devices

Timeline

1 Oct 2020	Recall initiated by company
8 Feb 2022	Classified by FDA	+495 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

Potential contamination with S. epidermidis E. coli and S. warneri.

Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.

Product as listed by the FDA

KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NM, NY, OH, OK, OR, PR, SC, TN, TX, VA, VT, WA, WV and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, FRANCE, GEORGIA, GERMANY, GUATAMALA, HONG KONG, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, JORDAN, LATVIA, MEXICO, NETHERLANDS, PERU, PHILIPPINES, POLAND, ROMANIA, SAUDI ARABIA, SOUTH AFRICA, SWITZERLAND, UNITED ARAB EMIRATES, VIETNAM.

Nationwide Arkansas Arizona California Colorado Delaware Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Maine Michigan Minnesota Mississippi Montana North Carolina

Questions about this recall

Why was it recalled?

Potential contamination with S. epidermidis E. coli and S. warneri.

Which lots are affected?

a. Catalog Number: 0947P; Lot Number: 947-126-2, 947-126-4; UDI: 20845357022947. b. Catalog Number: 0947K; Lot Number: 947-126-3; UDI: 30845357022951

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 89391

Reported	Class	Recall	Company	Reason	Where
16 Feb 2022	CLASS II	QC Sets and Panels GP Comprehensive QC Set recalled by Microbiologics	Microbiologics	E. coli	Nationwide
16 Feb 2022	CLASS II	Lyfo Disk(TM), Lyfo Disk(TM) Streptococcus pneumoniae recalled	Microbiologics	E. coli	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
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