Health product recall

CIC-C1q - Circulating Immune Complexes (CIC) ELISA

Last updated

Summary

Product
CIC-C1q - Circulating Immune Complexes (CIC) ELISA
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

CIC-C1q - Circulating Immune Complexes (CIC) ELISA

3836

EK-CIC

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

Additional information

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

Buhlmann Laboratories Ag

Baselstrasse 55, Schonenbuch, Switzerland, 4124

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76883

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