medical Class II Updated 2020-05-13

Inpeco S.A. recalls Inpeco FlexLab Centrifuge Module tube loading algorithm, Inp

Recalled Product

Inpeco FlexLab 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

Hazard / Issue

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

Issued by

FDA

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: FLX.002, FLX.006, FLX.008, FLX.011, FLX.0121, FLX.0127, FLX.0128, FLX.0129, FLX.0132, FLX.0133, FLX.0139, FLX.014, FLX.0147, FLX.0149, FLX.0150, FLX.0153, FLX.0154, FLX.0160, FLX.0162, FLX.0167, FLX.0168, FLX.0172, FLX.0173, FLX.0174, FLX.0179, FLX.0180, FLX.0182, FLX.0191, FLX.0192, FLX.0193, FLX.0194, FLX.0197, FLX.0198, FLX.0201, FLX.0202, FLX.0203, FLX.0206, FLX.022, FLX.032, FLX.035, FLX.036, FLX.037, FLX.039, FLX.043, FLX.046, FLX.050, FLX.056, FLX.057, FLX.060, FLX.061, FLX.062, FLX.073, FLX.082, FLX.083, FLX.085, FLX.086, FLX.087, FLX.093, FLX.096, FLX.097, FLX.098, FLX.100, SHD.001, SHD.002, SHD.003
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