Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access BR Monitor for use with the Access Family of Immunoassay Systems [Reference 387620; all non-expired lots and future lots].
Following biases observed in the results of the French National Quality Controls, the manufacturer has been informed that a study completed by the French Competent Authority Agence nationale de sécurité du Medicament et des produits de santé (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).
According to the manufacturer, the ANSM's preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the Access BR Monitor URL. The manufacturer is evaluating the Access BR Monitor cutoff. The conclusions of this evaluation are planned by the third Quarter of 2017.
Affected users are advised to ensure their laboratory staff and clinicians are aware of the limitations of the Access BR Monitor assay found in the IFU.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 April 2017