Health product recall

BD MAX SARS-CoV-2 Reagents (2020-07-27)

Starting date:
July 27, 2020
Posting date:
August 14, 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-73709

Last updated: 2020-08-14

Affected Products

BD MAX SARS-CoV-2 Reagents

Reason

BD has received reports from customers experiencing elevated rates of potential false positive results (approximately 2.8%) when using the BD MAX SARS-CoV-2 Reagents for the BD MAX system.

Affected products

BD MAX SARS-CoV-2 Reagents
Lot or serial number

All lots.

Model or catalog number

445003

Companies
Manufacturer
Becton Dickinson and Company
7 Loveton Circle
Sparks
21152
Maryland
UNITED STATES