Z-0641-2022Class III

KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis...

Name: Z-0641-2022 KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis...
Creator: Microbiologics Inc
Published: 2013-03-25
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2013-03-25 / Terminated / root cause: labeling and UDI

FDA source

Microbiologics Inc began a recall of KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM) on 2013-03-25. FDA classified it as Class III and gives the reason as "Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0641-2022
Classification: Class III
Status: Terminated
Initiated: 2013-03-25
Posted: 2022-02-14
Terminated: 2022-04-22
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Microbiologics notified customers on 03/25/2013 via letter titled "Important Medical Device Correction". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (KWIK-STIK" 01023P, Lot# 1023-05-7), it is recommended that the customer destroys the product. Microbiologics shall replace the destroyed product upon confirmation of destruction. Questions or concerns can be directed to the Customer Service Manager at 320.229.7057.
Quantity in commerce: 10 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
Product codes and lots: Catalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0641-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0641-2022	Class III	Terminated	Voluntary: Firm initiated	2022-02-23	2022-02-14

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)