Z-1957-2025Class II

KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from...

Name: Z-1957-2025 KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from...
Creator: Microbiologics Inc
Published: 2025-05-27
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2025-05-27 / Open, Classified / root cause: packaging

FDA source

Microbiologics Inc began a recall of KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived... on 2025-05-27. FDA classified it as Class II and gives the reason as "Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to...". 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-1957-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-27
Posted: 2025-06-11
Recalling firm: Microbiologics, Inc.
Product: KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: On May 27, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were informed of the affected products containing the wrong microorganisms. Customers were instructed to review lab procedures to understand how this information affects their usage, and then to use or discard the product depending on the lab procedures and how the issue affects usage. Distributors of the affected product were instructed to contact end users who have received the affected items.
Quantity in commerce: 3 total
Distribution: US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
Product codes and lots: 01065K: UDI-DI 30845357032868, lot 1065-25-51; 0621K: UDI-DI 30845357014666, lot 621-73-21

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1957-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1957-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11

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)