Z-0876-2026Class II

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog...

Name: Z-0876-2026 KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog...
Creator: Microbiologics Inc
Published: 2025-11-13
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2025-11-13 / Open, Classified / root cause: labeling and UDI

FDA source

Microbiologics Inc began a recall of KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K on 2025-11-13. FDA classified it as Class II and gives the reason as "Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0876-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-13
Posted: 2025-12-02
Recalling firm: Microbiologics, Inc.
Product: KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall notification letter dated 11/13/25 was sent to customers. INSTRUCTIONS: 1.CONTACT END USERS who have received or may have received the affected items above and provide them with the Customer Communication and Customer Response Forms. 2.COMPLETE the Distributor Response Form provided. 3.RETURN the response forms to [email protected]. 4.KEEP this letter for your records. 5.CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns. Collect calls may be made.
Quantity in commerce: 5 units
Distribution: International distribution to the countries of UAE, China, Singapore, Kazakhstan,
Product codes and lots: UDI-DI: 30845357020018; Lot Number: 818-111-7

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0876-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0876-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-02

Product code JTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)