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Z-0687-2013 Class II Terminated

Recalled by Perkinelmer — Waltham, MA

FDA device recall Z-0687-2013 was initiated by Perkinelmer on November 26, 2012 and is designated Class II. Reason for recall: Truncated V-Bottomed Microplate Wells used in assays contain defective wells. The recall status is terminated (terminated March 7, 2014). Affected quantity: 819 kits (10 plates/kit).

Recall Details

Product Type
Devices
Report Date
January 23, 2013
Initiation Date
November 26, 2012
Termination Date
March 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
819 kits (10 plates/kit)

Product Description

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 newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

Reason for Recall

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

Distribution Pattern

Nationwide Distribution.

Code Information

Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453

Other recalls by Perkinelmer

  • Z-0780-2017 Class II — PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. U (October 13, 2016)
  • Z-0747-2017 Class II — Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized (June 24, 2016)
  • Z-0632-2016 Class II — Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard (December 8, 2015)
  • Z-0634-2016 Class II — Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-00 (December 8, 2015)
  • Z-0633-2016 Class II — Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard (December 8, 2015)
  • Z-0635-2016 Class II — Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 (December 8, 2015)
  • Z-0636-2016 Class II — Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-015 (December 8, 2015)
  • Z-0637-2016 Class II — Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0 (December 8, 2015)
  • Z-0638-2016 Class II — Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The (December 8, 2015)
  • Z-2130-2015 Class II — Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The (June 3, 2015)

FDA data resources