Microbiologics Inc: Medical Device Recall in 2020 - (Recall #: Z-0402-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 8, 2020

Date Posted: November 11, 2020

Recall Number: Z-0402-2021

Event ID: 86574

Reason for Recall:

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

Status: Terminated

Product Quantity: 46 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated