FDA recall Z-1888-2020

Product

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

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

Key facts

Status

Ongoing

Initiation date

2020-04-07

Report date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lugano, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1888-2020