Z-0544-2022Class III

KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack...

Name: Z-0544-2022 KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack...
Creator: Microbiologics Inc
Published: 2021-02-24
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2021-02-24 / Terminated / root cause: labeling and UDI

FDA source

Microbiologics Inc began a recall of KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls on 2021-02-24. FDA classified it as Class III and gives the reason as "Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10". 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-0544-2022
Classification: Class III
Status: Terminated
Initiated: 2021-02-24
Posted: 2022-01-31
Terminated: 2022-07-11
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 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: 47 packs (94 units)
Distribution: US distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.
Product codes and lots: Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0544-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0544-2022	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)