Z-0584-2022Class II

QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each...

Name: Z-0584-2022 QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each...
Creator: Microbiologics Inc
Published: 2020-10-01
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2020-10-01 / Terminated

FDA source

Microbiologics Inc began a recall of QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism... on 2020-10-01. FDA classified it as Class II and gives the reason as "Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0584-2022
Classification: Class II
Status: Terminated
Initiated: 2020-10-01
Posted: 2022-02-08
Terminated: 2022-07-07
Recalling firm: Microbiologics, Inc.
Product: QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. 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.
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
FDA root cause: Unknown/Undetermined by firm
Action: Microbiologics notified customers on about 10/01/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions included the following: 1. REVIEW lab procedures to understand how this information affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3. COMPLETE the response form provided; 4. RETURN the response form to [email protected]; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or [email protected].
Quantity in commerce: 11 units
Distribution: 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.
Product codes and lots: Catalog Number: 5193P; Lot Number: 5193-10 (Expiration Date 09/30/2021), 5193-11 (Expiration Date 04/30/2021); UDI: 70845357030718

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0584-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0582-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0583-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-08
Z-0584-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-16	2022-02-08

Product code JTR

K861022Class IKwik Stik(tm) Lyfo(tm) Disk MicroorganismsMicro-Bio-Logics / cleared 1986-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)