MEDICAL DEVICE ALERT: SmartCheck INR system (28 February 2008)
The SmartCheck INR system blood coagulation test manufactured by Unipath is being recalled, because of a risk of inaccurate results leading to incorrect dosing of anticoagulants.
Although there have been no reported adverse incidents associated with
this device, the company has decided to recall SmartCheck INR meters
on the basis of a clinical study in which the performance of the device
did not meet its labelled claims.
Healthcare professionals should:
- Stop using the SmartCheck INR system
- Quarantine affected meters and
return them to Unipath
- Destroy consumables, test strips, control pack
and carry cases for all affected devices
- Review
patient results in parallel with the patient’s target therapeutic
range and the associated anticoagulant dose
- Contact patients whose
last dose adjustments were made using the SmartCheck INR system
and retest these patients using another method
Unipath can be contacted
on 01234
835811.
Technical queries about the device should be directed to Khalid Razak
or Moji Ajeneye at the Medicines and Healthcare products Regulatory
Agency on 020 7084
3200 or 020 7084 3271.
Clinical queries should be directed to Christopher
Brittain at the MHRA on 020 7084 3126. |
