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Access system - free t3 assays

Official notice

29 Mar 2023

Last checked

29 Mar 2023

Medium riskHealth Canada

An official Health Canada notice concerns Access system - free t3 assays. Beckman Coulter has determined that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are caused by insufficiently blocked interferents. Recall start date: March 20, 2023 Published 2023-03-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73409

Official notice

2023-03-29

The hazard

Beckman Coulter has determined that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are caused by insufficiently blocked interferents. Recall start date: March 20, 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

233968

Recall Numbers

73409

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Affected products

Product 1

Affected products - Unicel DxI 600 Access Immunoassay System - Free T3 Assay, Lot or serial number - 233968, Model or catalog number - A13422

Product 2

Affected products - Unicel DxI 800 Access Immunoassay System - Free T3 Assay, Lot or serial number - 233968, Model or catalog number - A13422

Product 3

Affected products - Access System - Free T3 Assay, Lot or serial number - 233968, Model or catalog number - A13422

Risk / hazard

Beckman Coulter has determined that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are caused by insufficiently blocked interferents. Recall start date: March 20, 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: Beckman Coulter, Access System - Free T3 Assays.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

73409

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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