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

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  Reason
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  Affected products

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