Health product recall

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

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

Klebsiella Pneumoniae Derived from NCTC 13439

Lot or serial number

1245-03-1
1245-03-2
1245-03-3
1245-03-4
1245-04-1

Model or catalog number

01245P

Companies
Manufacturer

Microbiologics, Inc.

200 Cooper Ave. N

St. Cloud

56303

Minnesota

UNITED STATES