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Triage Cardio3 Panel (2013-11-11)
- Starting date:
- November 11, 2013
- Posting date:
- January 6, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37305
Recalled products
- Triage Cardio3 Panel
Reason
Investigations have determined that this lot has an increased frequency of Troponin I results greater than 0.02 ng/mL for samples which are less than 0.02 ng/mL upon additional testing. Any questions about previously reported results, the recommendation would be to consult with your resident clinical expert or physician in the setting where the test was performed.
Affected products
A. Triage Cardio3 Panel
Lot or serial number
- W53657B
Model or catalog number
- 97400EU
Companies
- Manufacturer
-
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego
92121
California
UNITED STATES