The Recall Desk

FDA (Devices) recall action 85454

Inpeco S.A. recalled 2 products on 2020-05-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-05-20
Critical
0
Units
355

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    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 sa
    Category
    Distribution
    27 states
  • HighFDA (Devices)··2020-05-20

    Inpeco FlexLab Interface Module Recalled for Sample Cross-Contamination Risk

    Inpeco S.A. is recalling 82 FlexLab Interface Modules because a timeout error could cause sample cross-contamination.

    Product
    Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - 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
    Category
    Distribution
    27 states