Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
- Recall Initiated
- April 7, 2020
- Recall Number
- Z-1888-2020
- Quantity
- 23 units
Reason for Recall
The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
Distribution
Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri
Lot / Code Info
Serial Numbers: ACP.357, ACP.388, ACP.396, ACP.397, ACP.399, ACP.400, ACP.402, ACP.404, ACP.405, ACP.407, ACP.408, ACP.409, ACP.410, ACP.412, ACP.413, ACP.416, ACP.417, ACP.418, ACP.419, ACP.420, ACP.421, ACP.422, ACP.423
Root Cause
Software design (manufacturing process)
Action Taken
The firm sent an Urgent Medical Device Correction letter to all affected customers on March 30, 2020. The letter instructed the customers to complete and return the Customer Letter Receipt Confirmation and Implementation Check form. The firm explained that their regular service provider will contact them to schedule the firmware version upgrade.