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Z-0689-2013 Class II Terminated

Recalled by Perkinelmer — Waltham, MA

FDA device recall Z-0689-2013 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: 56 kits (100 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
56 kits (100 plates/kit)

Product Description

DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010

Reason for Recall

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

Distribution Pattern

Nationwide Distribution.

Code Information

Lot Numbers: 618609

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