Health product recall

DiaClon ABO/D+ Reverse-Group

Last updated

Summary

Product
DiaClon ABO/D+ Reverse-Group
Issue
Medical devices - Performance issue
What to do

Contact CDGCANADA_TECHNICALSERVICES@BIO-RAD.COM if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

DiaClon ABO/D+ Reverse-Group

All lots.

001236
001235
001234
001237

Issue

Bio-Rad Laboratories would like to inform its customers that user of IH-1000 and/or IH-500 may notice a slight increase in cases of visually interpreted "4+" reactions returned as double population "DP" by these instruments when using the DiaClon ABO/D+ Reverse-Group cards.

Recall start date: March 27, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies
Bio-Rad Medical Diagnostics Gmbh
Industriestr.1, Dreieich, Germany, 63303
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75368

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