No image published for this recall

No image published for this recall

Quantum blue adalimumab assay

Official notice

8 Dec 2021

Last checked

8 Dec 2021

Medium riskHealth Canada

An official Health Canada notice concerns Quantum blue adalimumab assay. Premature instability of Quantum Blue® Adalimumab Lot Series 3410 leading to an overestimation of Adalimumab trough levels with an approximate bias of +50%. Recall start date: Nov 25, 2021 Published 2021-12-08.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63694

Official notice

2021-12-08

The hazard

Premature instability of Quantum Blue® Adalimumab Lot Series 3410 leading to an overestimation of Adalimumab trough levels with an approximate bias of +50%. Recall start date: Nov 25, 2021

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.

Lots

Series

Recall Numbers

63694

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Affected products

Product 1

Affected Products - Quantum Blue Adalimumab Assay, Lot or serial number - 3410.N, Model or catalog number - LF-TLAD25

Risk / hazard

Premature instability of Quantum Blue® Adalimumab Lot Series 3410 leading to an overestimation of Adalimumab trough levels with an approximate bias of +50%. Recall start date: Nov 25, 2021

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 Adalimumab Assay.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63694

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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