Inpeco S.A. Via San Gottardo 10 Lugano Switzerland Siemens Aptio Automation 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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, CA, CT, DE, FL, IA, KY, LA, MD, MA, MI, MN, MO, MT, NE, NH, NJ, NM, NY, NC, OH, PA, RI, TN, TX, VA, WA