Z-0402-2021Class II

Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 -

Name: Z-0402-2021 Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 -
Creator: Microbiologics Inc
Published: 2020-10-08
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2020-10-08 / Terminated

FDA source

Microbiologics Inc began a recall of Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or... on 2020-10-08. FDA classified it as Class II and gives the reason as "Strain should be VIM-1 positive but is confirmed to be VIM-1 negative". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0402-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-08
Posted: 2020-11-05
Terminated: 2022-11-03
Recalling firm: Microbiologics, Inc.
Product: Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to verify the performance of assays, reagents or media that are intended to be used in microbial testing for the detection and identification of a cultured microorganism isolate.
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
FDA root cause: Under Investigation by firm
Action: Communication was extended to consignees that received product directly from the recalling firm. Distributors outside of the United States will be contacted via email, and if follow-up is required, the recalling firm's international sales team will contact the distributor to ensure that this communication is extended to their end-users. The recalling firm will work with the European Authorized Representative to coordinate all field safety corrective actions for consignees in the EU. The recalling firm will conduct effectiveness checks by contacting 100% of consignees that do not respond to the correspondence. This will be completed via phone or email.
Quantity in commerce: 46 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.
Product codes and lots: Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0402-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0402-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-05

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)