Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0402-2021

October 08, 2020

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 86574
Status
Terminated
Classification
Class II
Quantity
46 units
Official record key
device-enforcement:Z-0402-2021

Official wording

Reason: Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

Code information: Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.