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

QC Sets and Panels, Kwik-stik Blood Culture Identification recalled

Microbiologics is recalling QC Sets and Panels, Kwik-stik Blood Culture Identification (Bcid) Verification Panel, distributed nationwide in the US. The recall was initiated on 18 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 5229P; Lot Numbers (Expiration Date): 5229-01 (07/31/2020), 5229-02 (09/30/2020), 5229-03 (09/30/2020); UDI: 70845357038899

Quantity recalled3 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-0589-2022
FDA event ID: 89401
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2020
FDA classified: 8 Feb 2022
Reported: 16 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

18 Feb 2020	Recall initiated by company
8 Feb 2022	Classified by FDA	+721 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

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms

Where it was distributed

Worldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Number: 5229P; Lot Numbers (Expiration Date): 5229-01 (07/31/2020), 5229-02 (09/30/2020), 5229-03 (09/30/2020); UDI: 70845357038899

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

4 other products · FDA event 89401

This product is part of a recall event; the main page for the event is QC Sets and Panels, Kwik-stik Ast-gp (4 Strains) QC Set recalled.

Reported	Class	Recall	Company	Reason	Where
16 Feb 2022	CLASS II	QC Sets and Panels, Kwik-stik Ast-gp (4 Strains) QC Set recalled	Microbiologics	Potency & Assay	Nationwide
16 Feb 2022	CLASS II	Lyfo-disk Enterococcus faecalis derived from Atcc Vitro recalled	Microbiologics	Potency & Assay	Nationwide
16 Feb 2022	CLASS II	QC Sets and Panels, Kwik-stik Ast-gp (6 Strains) QC Set recalled	Microbiologics	Potency & Assay	Nationwide
16 Feb 2022	CLASS II	Kwik-stik, Quality control kit for culture media, sold as recalled	Microbiologics	Potency & Assay	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

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