Z-2576-2023Class III

KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing

Name: Z-2576-2023 KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Creator: Microbiologics Inc
Published: 2023-08-14
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2023-08-14 / Open, Classified / root cause: packaging

FDA source

Microbiologics Inc began a recall of KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing on 2023-08-14. FDA classified it as Class III and gives the reason as "One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2576-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-08-14
Posted: 2023-09-11
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Microbiologics issued an Urgent Medical Device Recall notice to its consignees by email on 08/14/2023. The notice explained the problem with the device and requested the consignee either use or discard the product depending on their lab procedures and how this information affects your usage. Contact Microbiologics if replacement kit is needed.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of MN, PA, TN, TX.
Product codes and lots: UDI/DI 70845357025622, Lot Number 5065-26, Exp. 07/31/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2576-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2576-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-11

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)