Home / Recalls / PerkinElmer, Inc / Z-0747-2017

Z-0747-2017 Class II Terminated

Recalled by PerkinElmer, Inc — Hopkinton, MA

FDA device recall Z-0747-2017 was initiated by PerkinElmer, Inc on June 24, 2016 and is designated Class II. Reason for recall: Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing The recall status is terminated (terminated July 31, 2018). Affected quantity: 595 trays (571,200 tips).

Recall Details

Product Type: Devices
Report Date: December 21, 2016
Initiation Date: June 24, 2016
Termination Date: July 31, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 595 trays (571,200 tips)

Product Description

Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows

Reason for Recall

Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing

Distribution Pattern

Worldwide Distribution - US including CA, MA, NY, IA, OR , PA, WA and Internationally to Belgium, Canada, Finland, France, Germany, Japan, Netherlands, Singapore, and UK

Code Information

Lot Numbers:15470394, 15471775, 1601067, 16071147

Other recalls by PerkinElmer, Inc

Z-0780-2017 Class II — PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. U (October 13, 2016)
Z-0634-2016 Class II — Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-00 (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-0636-2016 Class II — Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-015 (December 8, 2015)
Z-0632-2016 Class II — Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 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-0633-2016 Class II — Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard (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)
Z-2125-2015 Class II — WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma c (June 3, 2015)