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Health Canada Medical devices

CIC-C1q - Circulating Immune Complexes (CIC) ELISA

Issued January 30, 2025
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
Hazard description
Performance
Product
Product name
CIC-C1q - Circulating Immune Complexes (CIC) ELISA
Reference
ID
RA-76883