Microbiologics Inc: 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 inten

Is my product affected?

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.

• UPC 20845357040446

Check against the official notice below — it lists the full affected range.

What happened

Microbiologics Inc. is recalling Catalog 02145P Klebsiella pneumoniae control strain (derived from NCTC 13439) distributed worldwide across 46 units. The product was intended for use as a control to verify the performance of assays, reagents, or media. The strain is confirmed to be VIM-1 negative when it should be VIM-1 positive, making it unsuitable for its intended purpose.

The affected lots are 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, and 1245-04-1 under Catalog 01245P. The product was distributed in the United States and internationally to Austria, Canada, Chile, China, Germany, India, Ireland, Japan, Philippines, United Kingdom, and Vietnam. The source document does not specify what remedy affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 46 units Lot/code info: Catalog 01245P; Lots 1245-03-1, 1245-03-2, 1245-03-3, 1245-03-4, 1245-04-1 UDI: 20845357040446

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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