The Recall Desk
ModerateFDA (Devices)·Z-1887-2020·Announced 2020-05-13

Inpeco FlexLab Centrifuge Module Recalled for Potential Load Imbalance

Inpeco S.A. is recalling 65 FlexLab Centrifuge Modules because a tube loading algorithm defect may cause unbalanced loads that could damage the equipment.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the hazard is potential damage to the centrifuge with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Inpeco S.A. is recalling 65 units of the FlexLab Centrifuge Module (P/N: FLX-202) due to a defect in the tube loading algorithm. The affected units are equipped with specific firmware versions, including CM_1-7-0.H86, xCMd_2-5-0.elf, CM_1-7-1.H86, or xCMd_2-5-1-849fad9.elf.

The recall is necessary because the loading algorithm may lead to unbalanced loads during operation, which could result in damage to the centrifuge. The affected devices were distributed worldwide, including in numerous U.S. states such as Ohio, New York, Virginia, and California.

Users of these devices should stop using the affected FlexLab Centrifuge Modules and contact Inpeco S.A. for further instructions on how to resolve the issue.

The recalled product

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
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
65

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 27 states:

Part of a larger recall action

This product is one of 3 recalled by Inpeco S.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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