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SIMPLIRED D-DIMER (2016-05-31)
- Starting date:
- May 31, 2016
- Posting date:
- June 24, 2016
- 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-59020
A. SIMPLIRED D-DIMER
Reason
Data from long term stability monitoring shows that there is a decline in sensitivity performance of the SimpliRED D-dimer kits containing test reagent 1012-34437. This decline in sensitivity performance may affect qualitative results. False negative results are possible on the SimpliRED D-dimer test which may incorrectly influence the clinical diagnostic decision and could in some circumstances contribute to a delay in the diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE).
Affected products
A. SIMPLIRED D-DIMER
Lot or serial number
PW070A
Model or catalog number
DSRK4
Companies
- Manufacturer
-
BBI SOLUTIONS OEM LIMITED,
ALCHEMY HOUSE, TOM MCDONALD AVENUE
MEDIPARK, DUNDEE,
DD2 1NH
UNITED KINGDOM