The Recall Desk

FDA (Devices) recall action 75949

PerkinElmer Health Sciences, Inc. recalled 3 products on 2017-02-01

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
2017-02-01
Critical
0
Units
—

Why these products were recalled

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

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

States named across these recalls

1–3 of 3

  • LowFDA (Devices)··2017-02-01

    PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

    PerkinElmer is recalling AutoDELFIA systems with V3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven an
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-02-01

    PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures

    PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven a
    Category
    Distribution
    1 state
  • LowFDA (Devices)··2017-02-01

    PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures

    PerkinElmer is recalling AutoDELFIA systems with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.

    Product
    Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the p
    Category
    Distribution
    1 state