Public recall detail

CIC-C1q - Circulating Immune Complexes (CIC) ELISA

2025-01-30

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Recall Safety notice
Quick summary

Quick summary: CIC-C1q - Circulating Immune Complexes (CIC) ELISA. Date: 2025-01-30.

Recommended action

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

Recall details

Quick summary: CIC-C1q - Circulating Immune Complexes (CIC) ELISA. Date: 2025-01-30.

Official details

Affected product details

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

BrandBuhlmann Laboratories Ag
ProductCIC-C1q - Circulating Immune Complexes (CIC) ELISA
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76883

Affected products

ProductCIC-C1q - Circulating Immune Complexes (CIC) ELISA
Lot3836
ModelEK-CIC
Serial number3836
DescriptionCIC-C1q - Circulating Immune Complexes (CIC) ELISA

Issue

In-house testing with CIC lot 3836 has revealed unexpectedly elevated values in internal control serum samples exceeding the expected target range. Notably, samples with target values below 5 μg eq/ml showed increased results of up to 50% above their target hence, values of samples around the recommended cut-off (5 μg eq/ml) obtained with this lot could incorrectly exceed the true value of the sample, and thus potentially lead to inaccurate conclusions. Recall start date: January 17, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Immunology
CompaniesBuhlmann Laboratories Ag Baselstrasse 55, Schonenbuch, Switzerland, 4124
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76883
Background{}
CompaniesBuhlmann Laboratories Ag Baselstrasse 55, Schonenbuch, Switzerland, 4124
AudiencesHealthcare
Source updated2025-01-30

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

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