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Elecsys® troponin t hs

Official notice

31 Jan 2023

Last checked

31 Jan 2023

Medium riskHealth Canada

An official Health Canada notice concerns Elecsys® troponin t hs. During internal studies with the Elecsys® Troponin T hs (high sensitive) and Elecsys® Troponin T hs Stat assays, it was confirmed that for certain k2/k3 EDTA primary tubes, TnT hs results are elevated compared to serum samples when measured from the primary tube after processing the sample according to the tube manufacturers' instructions. This issue does not affect lithium heparin plasma or serum sample tubes. Recall start date: January 16, 2023 Published 2023-01-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72632

Official notice

2023-01-31

The hazard

During internal studies with the Elecsys® Troponin T hs (high sensitive) and Elecsys® Troponin T hs Stat assays, it was confirmed that for certain k2/k3 EDTA primary tubes, TnT hs results are elevated compared to serum samples when measured from the primary tube after processing the sample according to the tube manufacturers' instructions. This issue does not affect lithium heparin plasma or serum sample tubes. Recall start date: January 16, 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.

Recall Numbers

72632

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Affected products

Product 1

Affected products - Elecsys® Troponin T Hs, Lot or serial number - 61491501 64100801 63986301 64241701, Model or catalog number - 08469717190 08469873190

Product 2

Affected products - Elecsys® Troponin T Hs Stat, Lot or serial number - 59638102 56661101 59638101 63480901 56661102 56661103, Model or catalog number - 08469814190

Risk / hazard

During internal studies with the Elecsys® Troponin T hs (high sensitive) and Elecsys® Troponin T hs Stat assays, it was confirmed that for certain k2/k3 EDTA primary tubes, TnT hs results are elevated compared to serum samples when measured from the primary tube after processing the sample according to the tube manufacturers' instructions. This issue does not affect lithium heparin plasma or serum sample tubes. Recall start date: January 16, 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: Roche Diagnostics, Elecsys® Troponin T Hs.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

72632

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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