Home / Recalls / Perkinelmer / Z-0686-2013

Z-0686-2013 Class II Terminated

Recalled by Perkinelmer — Waltham, MA

FDA device recall Z-0686-2013 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: 180 kits (20 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
180 kits (20 plates/kit)

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.

Reason for Recall

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

Distribution Pattern

Nationwide Distribution.

Code Information

Lot Numbers: 617341, 619236

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-0636-2016 Class II — Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-015 (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-0638-2016 Class II — Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The (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-0634-2016 Class II — Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-00 (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