Reported May 20, 2020 · Terminated

Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage:…

Inpeco S.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Inpeco S.A. · Via San Gottardo 10 · Lugano, N/A · N/A

Is this the product you have?

  • Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module
  • Part NumbersACP-208-00 -
  • Product UsageThe FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation
Lot codes and dates
  • Serial Numbers

    273 of 273 codes

    • 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
    • ACP.026
    • ACP.027
    • ACP.028
    • ACP.029
    • ACP.030
    • ACP.031
    • ACP.032
    • ACP.033
    • ACP.034
    • ACP.035
    • ACP.036
    • ACP.038
    • ACP.041
    • ACP.042
    • ACP.043
    • ACP.044
    • ACP.045
    • ACP.046
    • ACP.047
    • ACP.048
    • ACP.049
    • ACP.050
    • ACP.051
    • ACP.052
    • ACP.053
    • ACP.055
    • ACP.056
    • ACP.057
    • ACP.058
    • ACP.059
    • ACP.060
    • ACP.061
    • ACP.063
    • ACP.064
    • ACP.066
    • ACP.067
    • ACP.068
    • ACP.069
    • ACP.070
    • ACP.071
Amount recalled
273

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 28, 2022 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.