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Unicel dxi 600 access immunoassay system- thyroglobulin assay

Official notice

23 Jul 2025

Last checked

23 Jul 2025

Medium riskHealth Canada
Watch Beckman Coulter

An official Health Canada notice concerns Unicel dxi 600 access immunoassay system- thyroglobulin assay. Multiple customers reported receiving high patient results when using access thyroglobulin reagent pack lot 439163. An internal review of batch records determined this was the first lot released using antibodies produced by BEC instead of a third party supplier. Recall start date: July 2, 2025 Published 2025-07-23.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77759

Official notice

2025-07-23

The hazard

Multiple customers reported receiving high patient results when using access thyroglobulin reagent pack lot 439163. An internal review of batch records determined this was the first lot released using antibodies produced by BEC instead of a third party supplier. Recall start date: July 2, 2025

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.

Lots

records, released

Recall Numbers

77759

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Affected products

Product 1

Affected products - Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay, Lot or serial number - 439163, Mode or catalogue number - 33860

Risk / hazard

Multiple customers reported receiving high patient results when using access thyroglobulin reagent pack lot 439163. An internal review of batch records determined this was the first lot released using antibodies produced by BEC instead of a third party supplier. Recall start date: July 2, 2025

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, Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter, Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77759

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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