FDAClass IIMay 13, 2020

Inpeco FlexLab Centrifuge Module tube loading algorithm recall

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…

Why was Inpeco FlexLab Centrifuge Module tube loading algorithm recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Inpeco S.A.
Quantity
65 units
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
Recall date
May 13, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls