Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning the following products:

• IMMAGE Immunochemistry System APB Apolipoprotein B Reagent
  • Reference: 447730
• IMMAGE Immunochemistry System LPAX Lipoprotein (a) Reagent
  • Reference: 447450
• IMMAGE Immunochemistry System PAB Prealbumin Reagent
  • Reference: 447440

The manufacturer has reported that the following chemistries fail to meet Instructions for Use or IFU lipid interference claims at the following levels:

• Low, mid, and high analyte levels of APB for actual triglyceride (TG) values in human serum ≥182 mg/dL, ≥219 mg/dL, and ≥355 mg/dL, respectively.
• Low and mid analyte levels of LPAX for actual TG values in intralipid ≥157 mg/dL and ≥636 mg/dL, respectively.
• Low, mid, and high analyte levels of PAB for actual TG values in human serum ≥202 mg/dL, ≥722 mg/dL, and ≥975 mg/dL, respectively.

According to the manufacturer, there is a remote probability of false high results for APB and PAB, and a false low result for LPAX. However, results for all analytes should still fall within total allowable error.

The manufacturer advised that IFUs are located on the Beckman Coulter website's Technical Documents section and affected users should follow the advice on "Resolution" of the notification letter as the information supersedes previous claims and serves as current labeling until the revised IFUs are released.

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

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

Posted on 1 March 2021