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