FDAFDA · Food and drugs·Recall number Z-0402-2021
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.
Published November 11, 2020 · Recall initiated: October 8, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.
- Lot
- Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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