Klebsiella Pneumoniae Derived from NCTC 13439 (2020-10-19)

Starting date:

October 19, 2020

Posting date:

October 30, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74215

Last updated: 2020-10-30

• Reason
• Affected products

Affected Products

Klebsiella Pneumoniae Derived from NCTC 13439

Reason

A complaint investigation identified that the lot numbers listed above do not contain the VIM-1 gene and are not metallo beta-lactamase positive. Identification of the loss of the VIM-1 gene was confirmed via Verigene Gram-Negative Blood Culture Nucleic Acid Test, metallo beta-lactamase (MBL) IP/IPI Etest and mCIM/eCIM testing. If this product is not used specifically for VIM-1/metallo beta-lactamase detection there will be no impact on the results.

Affected products