Health product recall

Dimension Exl System - Cardiac Troponin-I (CTnI) Assay

Last updated

Summary

Product
Dimension Exl System - Cardiac Troponin-I (CTnI) Assay
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Industry

Affected products

Affected products Lot or serial number Model or catalog number
Dimension Exl System - Cardiac Troponin-I (CTnI) Assay GA2323 RF421C

Issue

Siemens Healthcare Diagnostics Inc. has confirmed that Dimension Cardiac Troponin I (lTni and CTnI) lots (ea2314 and ga2323) shows a positive bias with lithium heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/ml. Troponin values as high as 0.20 ng/ml have been observed with lithium heparin plasma that are expected to be within the 99th percentile. Serum samples collected from normal, healthy individuals whose results fall within the reference interval or below the 99th percentile of 0.07 ng/ml were not impacted by this issue.

Recall start date: May 24, 2022

Additional information

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

Siemens Healthcare Diagnostics Inc.

500 Gbc Drive, Newark, Delaware, United States, 19714

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-64256