Z-0546-2022Class III

KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM)...

Name: Z-0546-2022 KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM)...
Creator: Microbiologics Inc
Published: 2020-12-16
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2020-12-16 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM) on 2020-12-16. FDA classified it as Class III and gives the reason as "The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have...". 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-0546-2022
Classification: Class III
Status: Terminated
Initiated: 2020-12-16
Posted: 2022-01-31
Terminated: 2023-01-12
Recalling firm: Microbiologics, Inc.
Product: KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. The KWIK-STIK negative control 0243U was labeled with an expiration date of 7/31/2020 when it should have been 7/31/2022.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Microbiologics notified customers on about 12/16/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to update records with the correct expiration date of 07/31/2022 and keep the letter for their records. Questions or concerns can be directed to Recall Support team at 320.229.7073 or [email protected].
Distribution: US Nationwide distribution in the states of AL, CA, CO, IL, MD, MO, MS, NM, OH, OR, PA, TX, VT.
Product codes and lots: Main Product Codes: Catalog Number: 8164, Lot Number: 8164-78, UDI: 70845357028623, Expiration date: 09/30/2021. Affected Component Codes: Catalog Number: 0243U, Lot Number: 243-48-5, UDI: 10845357004083, Expiration Date on Label: 07/31/2020, Correct Expiration Date: 07/31/2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0546-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0546-2022	Class III	Terminated	Voluntary: Firm initiated	2022-02-09	2022-01-31

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)