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