The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1889-2020·Announced 2020-05-13

Inpeco Siemens Aptio Centrifuge Module Recall for Tube Loading Algorithm Defect

Inpeco S.A. is recalling 313 Siemens Aptio Automation Centrifuge Modules because a tube loading algorithm may cause unbalanced loads that could damage the centrifuge.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the hazard involves potential equipment damage rather than direct patient injury or death, fitting the criteria for a moderate severity recall.

Plain-English summary

Inpeco S.A. is recalling 313 units of the Siemens Aptio Automation Centrifuge Module, specifically the tube loading algorithm with Inpeco S.A. P/N: FLX-202 and specific firmware versions. The recall is due to a defect in the loading algorithm that may lead to unbalanced loads, which could damage the centrifuge.

The affected units were distributed worldwide, including in numerous U.S. states such as Ohio, New York, Virginia, Pennsylvania, Texas, and California. The source text lists specific serial numbers for the affected devices, ranging from AP2.0001 to APT.0247.

Consumers and healthcare facilities should check their device serial numbers against the provided list. If a device is affected, users should contact Inpeco S.A. for instructions on how to proceed with the recall and remediation.

The recalled product

Product
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
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
313

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: AP2.0001
  • AP2.0002
  • AP2.0005
  • AP2.0008
  • AP2.0010
  • AP2.0011
  • AP2.0012
  • AP2.0013
  • AP2.0014
  • AP2.0016
  • AP2.0018
  • AP2.0019
  • AP2.0023
  • AP2.0024
  • AP2.0025
  • AP2.0026
  • AP2.0027
  • AP2.0032
  • AP2.0033
  • AP2.0034

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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