FDA recall Z-0402-2021

Microbiologics Inc · Class II · 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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-10-08
Report date
2020-11-11
Termination date
2022-11-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0402-2021