Health product recall

Access hsTnI

Last updated

Summary

Product
Access hsTnI
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Access hsTnI

All lots.

B52699

Issue

In remote circumstances, if a sample containing high cardiac troponin (CTNI) >55,000 pg/ml is tested using an access assay other than Access hsTnI, CTNI carryover may occur if the next test performed, using the same probe on that instrument, is Access hsTnI on a different sample.

Recall start date: November 18, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76641

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