Z-0307-2024Class II

KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)

Name: Z-0307-2024 KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Creator: Microbiologics Inc
Published: 2023-10-18
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2023-10-18 / Open, Classified

FDA source

Microbiologics Inc began a recall of KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) on 2023-10-18. FDA classified it as Class II and gives the reason as "A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0307-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-18
Posted: 2023-11-15
Recalling firm: Microbiologics, Inc.
Product: KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
FDA root cause: Under Investigation by firm
Action: Microbiologics issued an Urgent Medical Device Recall notice to its consignees on 10/18/2023 via email. The notice explained the issue and requested that the labs review their procedures to understand who the issue affects its usage, use or discard depending on its procedures, and contact Microbiologics if a replacement kit is needed. For questions or concerns contact the Recall Support team at 1.320.229.7073 or [email protected].
Quantity in commerce: 13 units
Distribution: Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
Product codes and lots: a) UDI/DI 20845357019169, Lot Numbers: 794-142-2, 794-142-4 b) UDI/DI 30845357019173, Lot Numbers: 794-142-3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0307-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0307-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-15
Z-0308-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-15

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)