Health product recall

Ih-Qc 3

Brand(s)
Last updated

Summary

Product
Ih-Qc 3
Issue
Medical devices - Increased risk or new adverse events
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Ih-Qc 3 08730 72 1 (SAP 709953 72 1) 009323

Issue

Following customers' feedback, we have been able to confirm that the results obtained with this Ih-Qc 3 batch may not be as expected. Different issues were observed which may cause Qc failed results:
a. Positive reactions may be observed in Direct Antiglobulin Tests (DAT)
b. Weaker or in worse case false negative reactions may occur with Rh:4 cells in Indirect Antiglobulin Test (IAT) and in 2-stage papain technique
c. When testing the impacted batch of Ih-Qc3 with Id-cards containing Anti-C, a double population with Anti-C (Rh:4) can be observed

Recall start date: Apr 25, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Diamed Gmbh

Pra Rond 23, Cressier Fr

Switzerland, 1785

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64140