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Health Canada Medical devices

Quantum Blue Anti-Infliximab

Issued February 14, 2022
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
Hazard description
Inaccurate test or measurement results
Product
Product name
Quantum Blue Anti-Infliximab
Reference
ID
RA-63919