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Immulite 2000 sytstem thyroglobulin assay

Official notice

5 Jan 2023

Last checked

5 Jan 2023

Medium riskHealth Canada
Watch Siemens

An official Health Canada notice concerns Immulite 2000 sytstem thyroglobulin assay. Siemens Healthcare Diagnostics Inc. Has confirmed through customer complaints the potential for functional sensitivity to not meet instructions for use (IFU) claims with the kit lots listed in table 1. Additionally, immulite thyroglobulin control module control level one may result outside of the published ranges. Per good laboratory practice, patient results are not reported when controls result out of range. Recall start date: December 15, 2022 Published 2023-01-05.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72403

Official notice

2023-01-05

The hazard

Siemens Healthcare Diagnostics Inc. Has confirmed through customer complaints the potential for functional sensitivity to not meet instructions for use (IFU) claims with the kit lots listed in table 1. Additionally, immulite thyroglobulin control module control level one may result outside of the published ranges. Per good laboratory practice, patient results are not reported when controls result out of range. Recall start date: December 15, 2022

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.

Recall Numbers

72403

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Affected products

Product 1

Affected products - Immulite 2000 Sytstem Thyroglobulin Assay, Lot or serial number - 436 431 433 434, Model or catalogue number - L2KTY2

Risk / hazard

Siemens Healthcare Diagnostics Inc. Has confirmed through customer complaints the potential for functional sensitivity to not meet instructions for use (IFU) claims with the kit lots listed in table 1. Additionally, immulite thyroglobulin control module control level one may result outside of the published ranges. Per good laboratory practice, patient results are not reported when controls result out of range. Recall start date: December 15, 2022

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

Siemens, Immulite 2000 Sytstem Thyroglobulin Assay

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens, Immulite 2000 Sytstem Thyroglobulin Assay.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

72403

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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