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Angiotensin Converting Enzyme (ACE) Kit (2014-01-10)
- Starting date:
- January 10, 2014
- Posting date:
- April 30, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39219
Recalled products
- Angiotensin Converting Enzyme (ACE) Kit
Reason
Control targets and ranges changed after assessment with several lots of reagents. Re-assignment of the control ranges.
Affected products
A. Angiotensin Converting Enzyme (ACE) Kit
Lot or serial number
- 043
- 044
Model or catalog number
- A-6040
Companies
- Manufacturer
-
Trinity Biotech PLC
Ida Business Park,
Bray, Wicklow
IRELAND