Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents [Reference numbers: 467825 (CHOL), A60298 (CR-E), A15625 (HDL), A95550 (LACT), 445850 (TG and TG-B), 442785 (URIC), 378194 (SALY); lot numbers: All].

The manufacturer has identified the drugs Metamizole (Dipyrone), Sulfasalazine and Sulfapyridine as potential sources of interference when using Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents. With the administration of these drugs, the effects to patient analytes are:

• Metamizole (Dipyrone) – may generate false low Cholesterol, Enzymatic Creatinine, HDL Cholesterol, Lactate, Triglycerides and Uric Acid results.
• Sulfasalazine – may generate false high Salicylate results.
• Sulfapyridine – may generate false low Salicylate results.

Information regarding interference with these drugs will be added to the Chemistry Information Sheets (CIS) for the respective products. The CIS will be updated on the Beckman Coulter website's Technical Documents webpage.

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 24 April 2017