Health product recall

Elecsys® Troponin T Hs

Last updated

Summary

Product
Elecsys® Troponin T Hs
Issue
Medical devices - Performance issue
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