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Beckman coulter au immunochemistry system- hdl ldl cholesterol assay

Official notice

10 Dec 2025

Last checked

10 Dec 2025

Medium riskHealth Canada
Watch Beckman Coulter

An official Health Canada notice concerns Beckman coulter au immunochemistry system- hdl ldl cholesterol assay. LDL cholesterol OSR6x96 does not meet the triglyceride interference claim per the BAOSR6x96 v10 IFU which states "no significant interference up to 1,500 mg/dl triglyceride" where the criteria for no significant interference is recovery within 10% of the initial value as outlined in the IFU. Published 2025-12-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81343

Official notice

2025-12-10

The hazard

LDL cholesterol OSR6x96 does not meet the triglyceride interference claim per the BAOSR6x96 v10 IFU which states "no significant interference up to 1,500 mg/dl triglyceride" where the criteria for no significant interference is recovery within 10% of the initial value as outlined in the IFU.

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Skus

OSR6196, OSR6296

Other

RA RA-81343

Model Numbers

OSR6196, OSR6296

Recall Numbers

81343

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue - OSR6196

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue - OSR6296

Risk / hazard

LDL cholesterol OSR6x96 does not meet the triglyceride interference claim per the BAOSR6x96 v10 IFU which states "no significant interference up to 1,500 mg/dl triglyceride" where the criteria for no significant interference is recovery within 10% of the initial value as outlined in the IFU.

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Beckman Coulter

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

81343

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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