Important Safety Alerts

Medical device manufacturer, Beckman Coulter, issued a medical device safety alert concerning its AU/DxC AU Uric Acid [Reference: OSR6x98; All Lots].

The manufacturer has determined that Uric Acid failed to meet the conjugated bilirubin interference specification for the serum application as defined in the IFU:

• Interference less than 10% up to 20 mg/dL or 342 μmol/L conjugated bilirubin

According to the manufacturer, two levels of Uric Acid serum pools (low and high) were tested. The low analyte pool with a concentration of 238 μmol/L was out of specification with a maximum bias of -11.06% at 20 mg/dL of conjugated bilirubin. The high analyte pool with a concentration of 416 μmol/L was out of specification with a maximum bias of -10.92% at 20 mg/dL of conjugated bilirubin. There is no conjugated bilirubin interference specification with the urine application.

According to the manufacturer, an interference due to a 20 mg/dL or 342 μmol/L conjugated bilirubin concentration may cause a:

• maximum negative bias up to -11.06% in low uric acid patient samples.
• maximum negative bias up to -10.92% in high uric acid patient samples.

This bias is not clinically significant.

The manufacturer will be updated the Uric Acid IFU (BLOSR6x98) Interference section with the following statement:

• Interference less than 12% or 35 μmol/L up to 20 mg/dL or 342 μmol/L conjugated bilirubin.

According to the local supplier, the affected devices are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 Dec 2021