Quantum Blue Anti-Infliximab
Brand(s)
Last updated
Summary
Product
Quantum Blue Anti-Infliximab
Issue
Medical devices - Inaccurate test or measurement results
What to do
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or Serial Number |
Model or catalog number |
|---|---|---|
Quantum Blue Anti-Infliximab |
1107.N |
LF-ADIF25 |
Issue
Positive, instead of negative, results have been reported by customers for the low control and patient samples for Quantum Blue® Anti-Infliximab production Series 1107. The increased false-positive rate was confirmed internally at Bühlmann. Approximately 80% of low control results and 24% of negative patients' samples are now expected to be false positive.
Recall start date: Jan 17, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Buhlmann Laboratories Ag
Baselstrasse 55, Schonenbuch
Switzerland, 4124
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63919
Get notified
Receive notifications for new and updated recalls and alerts by category.