Health product recall

BD MAX Enteric Bacterial Panel (2019-01-13)

Starting date:
January 13, 2019
Posting date:
January 31, 2019
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-68966

Affected Products

BD MAX Enteric Bacterial Panel

Reason

BD has observed a shift in PCR metrics for BD MAX Extended Enteric Bacterial Panel master mixes when used with sample buffer tubes from the affected BD MAX Enteric Bacterial Panel (EBP) lot. The result of this shift may cause false negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.

Affected products

BD MAX Enteric Bacterial Panel

Lot or serial number

8199682

Model or catalog number

442963

Companies
Manufacturer

Geneohm Sciences Canada, Inc.,

2555 Boul. Du Parc Technologique,

Québec, Québec

G1P 4S5

CANADA