Rappel de produits de santé

Data-Cyte Plus (2021-08-09)

Starting date:
August 9, 2021
Posting date:
August 19, 2021
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-76269



Last updated:
2021-08-19

Affected Products 

Data-Cyte Plus

Reason

During the manufacturer routine vigilance process, it has been detected that cell 10, (donor M6050AM) diluted to 0.8% for data-cyte plus 0.8%, ref. 213587 lot 610021015 exp. 2021-09-04, despite being typed as FYA+ (positive) and FYA+ (positive) during the bulk batch release and confirmed as positive in the final product release testing, has lost its reactivity over the time for these two antigens.

Affected products

Data-Cyte Plus

Lot or serial number

610021015

Model or catalog number

213587

Companies
Manufacturer

Medion Grifols Diagnostics AG

Bonnstrasse 9

Dudingen

3186

SWITZERLAND