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

QC Sets and Panels: Kwik-stik recalled by Microbiologics

Microbiologics is recalling QC Sets and Panels: Kwik-stik, distributed nationwide in the US. The recall was initiated on 1 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 8164; Lot Number (Expiration Date): 8164-45 (12/16/2015), 8164-46 (12/16/2015), 8164-47 (09/02/2016), 8164-48 (09/02/2016), and 8164-49 (10/03/2016); UDI: 70845357028623

Quantity recalled541 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-0703-2022
FDA event ID: 89517
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 1 Dec 2015
FDA classified: 1 Mar 2022
Reported: 9 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Dec 2015	Recall initiated by company
1 Mar 2022	Classified by FDA	+2282 days
9 Mar 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 Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356

Where it was distributed

US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, NC, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI, WV, WY.

Nationwide Arizona California Colorado Florida Georgia Hawaii Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Minnesota North Carolina New Mexico New York Ohio Oregon Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Number: 8164; Lot Number (Expiration Date): 8164-45 (12/16/2015), 8164-46 (12/16/2015), 8164-47 (09/02/2016), 8164-48 (09/02/2016), and 8164-49 (10/03/2016); UDI: 70845357028623

Where was it sold?

US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, NC, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI, WV, WY.

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

1 other product · FDA event 89517

This product is part of a recall event; the main page for the event is QC Sets and Panels: Kwik-stik Cepheid Smart GBS QC Set recalled.

Reported	Class	Recall	Company	Reason	Where
9 Mar 2022	CLASS II	QC Sets and Panels: Kwik-stik Cepheid Smart GBS QC Set recalled	Microbiologics	Device Malfunction	Nationwide

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