Z-1125-2022Class III

KWIK-STIK" plus: Clostridium perfringens

Name: Z-1125-2022 KWIK-STIK" plus: Clostridium perfringens
Creator: Microbiologics Inc
Published: 2022-05-06
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2022-05-06 / Terminated / root cause: labeling and UDI

FDA source

Microbiologics Inc began a recall of KWIK-STIK" plus: Clostridium perfringens on 2022-05-06. FDA classified it as Class III and gives the reason as "Labeling error". 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-1125-2022
Classification: Class III
Status: Terminated
Initiated: 2022-05-06
Posted: 2022-05-23
Terminated: 2024-01-16
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK" plus: Clostridium perfringens
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Labeling error.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm issued a recall notification to the consignees beginning on 05/06/2022 via email. The letter informs the consignee to inspect inventory, review lab procedures, use or discard affected product depending on lab procedures, and complete the response form.
Quantity in commerce: 8 units
Distribution: Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.
Product codes and lots: catalog number: 0801P; lot number: 801-44-4; expiration date: 05/31/2023; UDI: 20845357019374

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1125-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1125-2022	Class III	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)