Events

Recall of Device Recall Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Perkinelmer.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63771
  • Event Risk Class
    Class 2
  • Event Number
    Z-0686-2013
  • Event Initiated Date
    2012-11-26
  • Event Date Posted
    2013-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115038
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine - Product Code JNB
  • Reason
    Truncated v-bottomed microplate wells used in assays contain defective wells.
  • Action
    Perkin Elmer initiated the recall on November 23, 2012. The Recall Letter will be delivered to the end customer by email facilitated through our PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: - Inspect the wells of row A and row H of the affected microplate lots for possible holes and cracks prior to use. - If a hole or crack is visually detected in a well of the microplate, the well should not be used for testing. - If a hole or crack is not visually detected in a well of the plate, it is required during use of the well, the volume of solution in the well should be visually confirmed to be consistent before and after incubation. Please contact PerkinEimer Technical Support for further information (800) 321 -9632, select prompt 2.

Device

Device Recall Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM
  • Model / Serial
    Lot Numbers: 617341, 619236
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
  • Manufacturer
    Perkinelmer

Manufacturer

Perkinelmer
  • Manufacturer Address
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA