Important Safety Alerts

Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. The affected products are identified as follows:

• UniCel DxH 800 Coulter Cellular Analysis System
  • Reference.: 629029, B24465, B24802, B68304
  • Software version: 2.0.0.0 and greater
• UniCel DxH 600 Coulter Cellular Analysis System
  • Reference: B23858
  • Software version: 1.0.0.0 and greater

The manufacturer has identified an issue where the RBC aperture baths can contain residue in the sweep flow fittings. This residue may potentially create increased background failures, flagged results and vote outs for RBC and PLT parameters.

Affected users are instructed to:

• address any Daily Checks system alarms and background failures as indicated in the Online Help or Instructions for Use (part number B26647AC and B16421AD); and
• monitor flags on patient and control results according to their laboratory protocols.

According to the local supplier, UniCel DxH 800 Coulter Cellular Analysis System is distributed in Hong Kong.

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

Posted on 9 May 2016