Health product recall

Quantum Blue Anti-Infliximab

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: 2022-02-16
Alert / recall type
Health product recall
Category
Health product - Medical device - 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