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Bioplex 2200 anti-ccp system

Official notice

9 Mar 2023

Last checked

9 Mar 2023

Critical riskHealth Canada

An official Health Canada notice concerns Bioplex 2200 anti-ccp system. Bio-Rad Laboratories has received reports of discrepant results with the md lot # 301481 #53727. False positive Anti-CCP results may lead to incorrect diagnosis of rheumatoid arthritis and unnecessary medical treatment. Recall start date: February 22, 2023 Published 2023-03-09.

What to do now

Bio-rad laboratories (canada) ltd. Diagnostics group cdgcanada_technicalservices@bio-rad.com

Recall number

73118

Official notice

2023-03-09

The hazard

Bio-Rad Laboratories has received reports of discrepant results with the md lot # 301481 #53727. False positive Anti-CCP results may lead to incorrect diagnosis of rheumatoid arthritis and unnecessary medical treatment. Recall start date: February 22, 2023

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

301481

Recall Numbers

73118

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Affected products

Product 1

Affected products - Bioplex 2200 Anti-CCP Calibrator Set, Lot or serial number - 53727, Model or catalog number - 663-3200

Product 2

Affected products - Bioplex 2200 System Anti-CCP, Lot or serial number - 301481, Model or catalog number - 665-3250

Risk / hazard

Bio-Rad Laboratories has received reports of discrepant results with the md lot # 301481 #53727. False positive Anti-CCP results may lead to incorrect diagnosis of rheumatoid arthritis and unnecessary medical treatment. Recall start date: February 22, 2023

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: Bio-rad Laboratories, Bioplex 2200 Anti-ccp System.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

73118

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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