The Recall Desk

FDA (Devices) recall action 63771

Perkinelmer recalled 5 products on 2013-01-23

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2013-01-23
Critical
0
Units
—

Why these products were recalled

Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

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

1–5 of 5

  • ModerateFDA (Devices)··2013-01-23

    Perkinelmer Recalls Neonatal Total Galactose Kits Due to Defective Microplate Wells

    Perkinelmer is recalling Neonatal Total Galactose Kits because the microplate wells used in the assays are defective, which may affect the accuracy of newborn screening results.

    Product
    NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper a
    Category
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    0 states
  • ModerateFDA (Devices)··2013-01-23

    Perkinelmer Recalls Defective DBS Microplates for Assay Use

    Perkinelmer is recalling 56 kits of DBS Microplates, Truncated V-Bottomed, due to defective wells that may affect assay results.

    Product
    DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-01-23

    Perkinelmer Recalls Defective NEOGRAM Tandem Mass Spectrometry Kits

    Perkinelmer is recalling 180 NEOGRAM Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kits because they contain defective microplate wells.

    Product
    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper
    Category
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    0 states
  • HighFDA (Devices)··2013-01-23

    Perkinelmer Recalls NEOBASE MSMS Kits Due to Defective Microplate Wells

    Perkinelmer is recalling NEOBASE Non-Derivatized MSMS Kits because the microplate wells used in the assays are defective. This may affect the accuracy of newborn metabolic disorder screening.

    Product
    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from
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    0 states
  • HighFDA (Devices)··2013-01-23

    Perkinelmer Recalls Defective Truncated V-Bottomed Microplates

    Perkinelmer is recalling specific lots of truncated V-bottomed microplates because the wells are defective. These products are used for preparing and examining human body specimens.

    Product
    Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
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    0 states