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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 166 02 12 000
Date submitted: 2/25/2012
Manufacturer:BIONIME Corporation
Device Type:Blood glucose test strip
Description:Test, strip, glucose
Medical Device Identifier:Mylife Pura tests strip Model : GS550
Reason of Field Safety Corrective Action:Potential strip vials opening in a very small amount of boxes of 100 mylife TN Pura® during transportation from the Warehouse in France to the Pharmacies (and Patients). Test strips are very sensitive towards air exposure and therefore, if strips are exposed to warm and humid air in open condition, they may lose its performance (accumulated conditions: Open Vial + Humidity + High Temperature + Time). The consequence may be abnormal high readings, in which case the patient may follow unsuited treatment because of inaccurate glycaemia levels and with the consequence of potential risk of hypoglycemia
Remedy Action:Stop using potentially affected unsealed strip lots. Return potentially affected unsealed strip lots to the pharmacy where the strips were purchased. All strip lots will be fully refunded and refurnished with new sealed strip lots
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:FR-2012-02-21-011
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments