Reverse-Cyte 0.8% (2020-04-22)
- Starting date:
- April 22, 2020
- Posting date:
- May 15, 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-73087
Last updated: 2020-05-15
Affected Products
Reverse-Cyte 0.8%
Reason
In affected kits, a 10% incidence of false positive reactions was observed with the use of these cells.
Affected products
Reverse-Cyte 0.8%
Lot or serial number
- 630520007
Model or catalog number
- 213598
Companies
- Manufacturer
-
Medion Grifols Diagnostics AG
Bonnstrasse 9
Dudingen
3186
SWITZERLAND