The Recall Desk

FDA (Devices) recall action 72808

Perkinelmer recalled 7 products on 2016-01-20

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2016-01-20
Critical
0
Units
430

Why these products were recalled

The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.

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.

1–7 of 7

  • ModerateFDA (Devices)··2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Incorrect Barcode Label

    Perkinelmer is recalling four WIZARD2 gamma counters because a barcode label misidentifies sample ID #023 as #024, which may cause the device to execute the wrong measurement protocol and produce erroneous results.

    Product
    Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-01-20

    Perkin Elmer ClWIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 62 ClWIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The Wizard2 gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error

    Perkinelmer is recalling 60 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, leading to erroneous results.

    Product
    Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 47 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recall Due to Barcode Label Error

    Perkinelmer is recalling 47 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 22 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-01-20

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 188 WIZARD2 gamma counters because a barcode label error may cause the device to execute the wrong measurement protocol, potentially producing erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples
    Category
    Distribution
    0 states