Access hsTnI Reagent (2018-10-15)
- Starting date:
- October 15, 2018
- Posting date:
- November 28, 2018
- 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-68382
Affected products
Access hsTnI Reagent
Reason
The Cardiac Troponin T Cross Reactivity concentration of 253 ng/ml (253,000 pg/ml) previously listed in the access HSTNI Instructions For Use (IFU) does not apply to samples with HSTNI concentrations less than 16 pg/ml (ng/l).
Samples containing cardiac troponin t concentrations > 125 ng/ml (125,000 pg/ml) may cross react with the access HSTNI assay:
- access HSTNI results may change by more than 10% for HSTNI sample concentrations greater than 11.5 pg/ml (ng/l);
- access HSTNI results may change by more than 2.30 pg/ml (ng/l) for HSTNI sample concentrations less than or equal to 11.5 pg/ml (ng/l).
Affected products
Access hsTnI Reagent
Lot or serial number
All lots.
Model or catalog number
- B52699
Companies
- Manufacturer
-
Immunotech SAS
130 AVENUE DE LATTRE DE TASSIGNY
MARSEILLE CEDEX 09,
13276
FRANCE