Data-Cyte Plus (2021-08-09)

Starting date:

August 9, 2021

Posting date:

August 27, 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-76313

Last updated: 2021-08-27

• Reason
• Affected products

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 FYB+ (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