Public recall detail

IH-500

2022-10-13

medium
Recall Safety notice
Quick summary

Quick summary: IH-500. Date: 2022-10-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: IH-500. Date: 2022-10-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandDiamed Gmbh
ProductIH-500
IssueMedical devices - Performance
Recall classType II
IdentificationRA-72020

Affected products

ProductIH-500
LotAll lots.
Model001500
Serial numberAll lots.
DescriptionIH-500
ProductDiaclon Abo/D+Reverse-Group
LotAll lots.
Model001236 001235 001234 001237
Serial numberAll lots.
DescriptionDiaclon Abo/D+Reverse-Group
ProductDiaclon Anti-N
LotAll lots.
Model00711
Serial numberAll lots.
DescriptionDiaclon Anti-N
ProductDiaclon Abd Confirmation For Donors
LotAll lots.
Model001135 001136 001134 001133
Serial numberAll lots.
DescriptionDiaclon Abd Confirmation For Donors
ProductDiaclon Rh-Subgroup+K
LotAll lots.
Model002127 002125 002126 002124
Serial numberAll lots.
DescriptionDiaclon Rh-Subgroup+K
ProductDiaclon Anti-M
LotAll lots.
Model007011
Serial numberAll lots.
DescriptionDiaclon Anti-M
ProductDiaclon Abd Confirmation For Patients
LotAll lots.
Model001255 001256 001254 001257
Serial numberAll lots.
DescriptionDiaclon Abd Confirmation For Patients

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

What you should do

  • Contact BIO-RAD LABORATORIES (CANADA) LTD. if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Haematology
CompaniesDiamed Gmbh Pra Rond 23, Cressier Fr, Switzerland, 1785
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72020
Background{}
CompaniesDiamed Gmbh Pra Rond 23, Cressier Fr, Switzerland, 1785
AudiencesHealthcare
Source updated2022-10-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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