Health product recall

Elecsys® Troponin T Hs

Last updated

Summary

Product
Elecsys® Troponin T Hs
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

Elecsys® Troponin T Hs

61491501
64100801
63986301
64241701

08469717190
08469873190

Elecsys® Troponin T Hs Stat

59638102
56661101
59638101
63480901
56661102
56661103

08469814190

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Roche Diagnostics GmbH

Sandhoferstrasse 116, Mannheim, Germany, 68305

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-72632

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