No image published for this recall

No image published for this recall

Quantum blue anti-infliximab

Official notice

14 Feb 2022

Last checked

14 Feb 2022

Medium riskHealth Canada

An official Health Canada notice concerns Quantum blue anti-infliximab. 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 Published 2022-02-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63919

Official notice

2022-02-14

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63919

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Affected products

Product 1

Affected Products - Quantum Blue Anti-Infliximab, Lot or Serial Number - 1107.N, Model or catalog number - LF-ADIF25

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Buhlmann Laboratories, Quantum Blue Anti-infliximab.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63919

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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