Health product recall

IH-500

Brand(s)
Last updated

Summary

Product
IH-500
Issue
Medical devices - Performance issue
What to do

Contact BIO-RAD LABORATORIES (CANADA) LTD. if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

IH-500

All lots.

001500

Diaclon Abo/D+Reverse-Group

All lots.

001236
001235
001234
001237

Diaclon Anti-N

All lots.

00711

Diaclon Abd Confirmation For Donors

All lots.

001135
001136
001134
001133

Diaclon Rh-Subgroup+K

All lots.

002127
002125
002126
002124

Diaclon Anti-M

All lots.

007011

Diaclon Abd Confirmation For Patients

All lots.

001255
001256
001254
001257

Issue

In case of absence of red blood cells (RBC) sample into the anti-A well or anti-B well, the reading algorithm of the IH-500 might not be able to properly detect the dispense failure and return the result as positive instead of empty "e". 

Recall start date: September 23, 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
Healthcare
Recall class
Type II
Identification number
RA-72020

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