BioPlex 2200 EBV IgM Control Set (2018-11-21)
- Starting date:
- November 21, 2018
- Posting date:
- December 10, 2018
- 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-68558
Affected products
BioPlex 2200 EBV IgM Control Set
Reason
Internal manufacturer's investigation has confirmed reports of the heterophile QC level 2 being out of range at the lower manufacturing limit when using EBV IgM QC.
Affected products
BioPlex 2200 EBV IgM Control Set
Lot or serial number
50442
Model or catalog number
6631330
Companies
- Manufacturer
-
Bio-Rad Laboratories Clinical Diagnostics Group
4000 Alfred Nobel Drive
Hercules
94547
California
UNITED STATES