CIC-C1q - Circulating Immune Complexes (CIC) ELISA
Brand(s)
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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