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.
Reported: November 11, 2020 Initiated: October 8, 2020 #Z-0402-2021
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.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 46 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Microbiologics Inc. Units affected: 46 units.
Why was this product recalled? ▼
Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0402-2021.
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