The Recall Desk

FDA (Devices) recall action 85444

Inpeco S.A. recalled 3 products on 2020-06-03

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-06-03
Critical
0
Units
110

Why these products were recalled

The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.

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

1–3 of 3

  • ModerateFDA (Devices)··2020-06-03

    Inpeco Accelerator a3600 Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling three Accelerator a3600 Automation Systems due to a firmware communication error that can cause incorrect sample-tube associations.

    Product
    Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analyt
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2020-06-03

    Inpeco Aptio Automation System Recalled for Sample Association Error

    Inpeco S.A. is recalling 70 Aptio Automation Systems with specific interface modules due to a firmware communication error that can cause erroneous sample-tube associations.

    Product
    Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-A
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2020-06-03

    Inpeco FlexLab Automation System Recalled for Sample Association Errors

    Inpeco S.A. is recalling 37 FlexLab Automation Systems due to a firmware communication error that can cause sample tubes to be incorrectly associated with carriers.

    Product
    FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is a modular system designed to automate Pre-Analytical and Post-Analytical proces
    Category
    Distribution
    3 states