Lower risk Medical device recall · FDA · Published February 18, 2020

Microbiologics QC Sets May Give Incorrect Test Results

Microbiologics recalls QC sets and KWIK-STIK AST-GP kits that may return incorrect bacterial susceptibility results, affecting lab testing accuracy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0587-2022Medical device Microbiologics ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440

✎ GovInfoNow plain-language explainer

Microbiologics is recalling QC sets and KWIK-STIK AST-GP kits that may give incorrect test results for bacterial susceptibility. This could lead to inaccurate lab results and improper treatment decisions. Read more at govinfonow.com/recall/65811-microbiologics-qc-sets-may-give-incorrect-test-results.

Source Summary by GovInfoNow · govinfonow.com/recall/65811-microbiologics-qc-sets-may-give-incorrect-test-results · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0587-2022

Cite this page

“Microbiologics QC Sets May Give Incorrect Test Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/65811-microbiologics-qc-sets-may-give-incorrect-test-results. Based on FDA recall #Z-0587-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0587-2022%22&limit=1).

The FDA announced on 2020-02-18 that Microbiologics Inc is recalling QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set due to a risk of incorrect susceptible test results. The agency classified the recall as Class II.

How to tell if you have it

Brand: Microbiologics
Product: QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set
Catalog Number: 0959P
Catalog Number: 5112P
Lot Numbers: 5112-01 (Expiration Date 07/31/2020), 5112-02 (Expiration Date 10/31/2020)
UDI: 70845357026551

The hazard

GovInfoNow's records show the recalled kits may return incorrect susceptible results. The 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.

Context

GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since 2017-06-06. Other recent recalls of similar products include Microbiologics KWIK-STIK 6-Pack Recall (2025-12-02), Microbiologics KWIK-STIK Quality Control Kit Recall (2025-11-13), and Microbiologics LYFO-DISK Recall (2025-06-27).

How to tell if you have this one

Check for the KWIK-STIK AST-GP (4 Strains) QC Set with Catalog Number 0959P. Lot numbers 5112-01 (expiring 07/31/2020) or 5112-02 (expiring 10/31/2020) are affected.

Brand
Microbiologics
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
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.

Recall number	Product, codes & lots	Quantity
Z-0585-2022	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; a. Catalog Number 0959P, UDI: 20845357023210, Lot Number (Expiration Date): 959-94-3 (04/30/2020), 959-95-2 (09/30/2020), 959-96-1 (12/31/2020), 959-96-4 (12/31/2021), 959-97-4 (03/31/2021), 959-97-5 (03/31/2021); b. Catalog Number 0959K, UDI: 30845357023224, Lot Number (Expiration Date): 959-94-2 (04/30/2020), 959-95-1 (09/30/2020), 959-95-5 (09/30/2020), 959-96-3 (12/31/2020), 959-97-1 (03/31/2021), 959-97-6 (03/31/2021);	1,975 units
Z-0586-2022	LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms; Specific codes for Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-94-1 (04/30/2020), 959-94-4 (04/30/2020), 959-95-3 (09/30/2020), 959-96-2 (12/31/2020), 959-97-3 (03/31/2021).	183 units
Z-0587-2022	QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms; Catalog Number: 5112P; Lot Numbers: 5112-01 (Expiration Date 07/31/2020), 5112-02 (Expiration Date 10/31/2020); UDI: 70845357026551	10 units
Z-0588-2022	QC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms; Catalog Number: 5220P; Lot Numbers (Expiration Date): 5220-01 (04/30/2020), 5220-02 (07/31/2020), 5220-03 (10/31/2020), 5220-04 (10/31/2020), 5220-05 (10/31/2020), 5220-06 (01/31/2021); UDI: 70845357026551	139 units
Z-0589-2022	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; Catalog Number: 5229P; Lot Numbers (Expiration Date): 5229-01 (07/31/2020), 5229-02 (09/30/2020), 5229-03 (09/30/2020); UDI: 70845357038899	3 units

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the catalog number (0959P) and lot numbers (5112-01 or 5112-02) to confirm if your kit is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Feb 18, 2020Firm started the recall
Feb 8, 2022FDA classified it Class II
Feb 16, 2022Published in FDA’s Enforcement Report
Jul 11, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/65811-microbiologics-qc-sets-may-give-incorrect-test-results">Microbiologics QC Sets May Give Incorrect Test Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0587-2022 (February 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0587-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.