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The official notice did not include a photo. Check the product details and identifiers below.
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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
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
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.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Siemens, Immulite 2000 Sytstem Thyroglobulin Assay.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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