The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2004-2020·Announced 2020-05-20

Inpeco Abbott Accelerator a3600 Interface Module Recalled for Cross-Contamination Risk

Inpeco S.A. is recalling 273 Abbott Accelerator a3600 Interface Modules because a timeout error could cause sample cross-contamination.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (cross-contamination) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Inpeco S.A. is recalling 273 units of the Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module (Part Number ACP-208-00). The recall is classified as Class II by the U.S. Food and Drug Administration. The affected modules are part of a modular system designed to automate pre-analytical and post-analytical processing and sample handling in laboratories.

The recall was initiated because when the analyzer sample carousel lid remains open or a manual process takes too long, module timeout expiry errors can occur. These errors could cause cross-contamination of samples. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

The affected units were distributed worldwide and nationwide in the United States, including in Texas, West Virginia, South Carolina, Delaware, Louisiana, Illinois, Georgia, Florida, New York, Virginia, Arkansas, Wisconsin, California, Minnesota, Missouri, North Carolina, Utah, Michigan, Ohio, Alabama, Oklahoma, Tennessee, Kansas, Hawaii, Arizona, and Washington. Users should check their serial numbers against the provided list and contact the recalling firm for instructions.

The recalled product

Product
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate…
Manufacturer
Inpeco S.A.
Category
Medical Device — Laboratory Automation
Hazard
Affected units
273

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: ACP.001
  • ACP.002
  • ACP.003
  • ACP.004
  • ACP.007
  • ACP.008
  • ACP.010
  • ACP.011
  • ACP.013
  • ACP.014
  • ACP.015
  • ACP.016
  • ACP.017
  • ACP.018
  • ACP.019
  • ACP.020
  • ACP.022
  • ACP.023
  • ACP.024
  • ACP.025

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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