Z-0581-2022Class III

KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)

Name: Z-0581-2022 KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Creator: Microbiologics Inc
Published: 2020-10-08
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2020-10-08 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) on 2020-10-08. FDA classified it as Class III and gives the reason as "The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0581-2022
Classification: Class III
Status: Terminated
Initiated: 2020-10-08
Posted: 2022-02-08
Terminated: 2022-07-07
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Microbiologics notified customers on about 10/08/2020 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 [email protected].
Quantity in commerce: 187 units
Distribution: US distribution to . International distribution to Austria, Botswana, Brazil, Canada, China, Colombia, Finland, France, Germany, Guatemala, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mauritius, Netherlands, Norway, Oman, Peru, Poland, Romania, South Africa, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam
Product codes and lots: Catalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0581-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0581-2022	Class III	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)