Z-0402-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2020
- Initiation Date
- October 8, 2020
- Termination Date
- November 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
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.
Reason for Recall
Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.
Code Information
Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446