Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its MicroScan Dried Gram Positive Combo and ID [Multiple reference numbers, lot numbers and expiry date].
The manufacturer has confirmed that false positive results may occur on autoSCAN-4 (AS4) instrument read with Micrococcus Screen (MS) vs. quality control (QC) organism Micrococcus luteus ATCC 49732 and/or clinical isolates and Identification substrate Bacitracin (BAC) with clinical isolates. A QC failure for MS or misidentification due to false positive MS and/or BAC may occur.
The manufacturer is investigating the root cause of this issue and appropriate actions to prevent recurrence will be implemented. Affected users should follow the action shown on the customer letter issued by the manufacturer.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 Sep 2021