Recall MonitorHealth Products
CIC-C1q - Circulating Immune Complexes (CIC) ELISA
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Immunology
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
Recall class: Type II
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