Important Safety Alerts

Beckman Coulter has issued a medical device safety alert concerning its COULTER 4C-ES Cell Controls.

The manufacturer has confirmed intermittent asterisk (*) flags on WBC and differential parameters for the Abnormal Low control. According to the manufacturer, patient results are not affected. A delay in the reporting of patient results is not expected to occur. Normal and Abnormal High controls are not affected.

The following actions are recommended to affected users by the manufacturer:

• If the recovered results for the WBC and differential parameters are within the values in the Table of Expected Results for the Abnormal Low control, values can be accepted.
• If the recovered results are not within the values stated in the Table of Expected Results for the Abnormal Low Control, perform the actions in Table 6.4 of instrument's Instructions for Use.
• Follow laboratory protocol for asterisk (*) flags on patient samples.

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 26 Oct 2021