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Class 2 Device Recall Pipette tips: Item Number: 6000689 25 L Clear Filter Sterile Roborack, Qty 960 |
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Date Initiated by Firm |
June 24, 2016 |
Create Date |
December 12, 2016 |
Recall Status1 |
Terminated 3 on July 31, 2018 |
Recall Number |
Z-0747-2017 |
Recall Event ID |
75508 |
Product Classification |
Station, pipetting and diluting, for clinical use - Product Code JQW
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Product |
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 |
Code Information |
Lot Numbers:15470394, 15471775, 1601067, 16071147 |
Recalling Firm/ Manufacturer |
PerkinElmer, Inc 68 Elm St Hopkinton MA 01748-1602
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For Additional Information Contact |
508-435-9500
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Manufacturer Reason for Recall |
Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
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FDA Determined Cause 2 |
Process control |
Action |
PerkinElmer initiated recall on June 24, 2016 to the Product Manager and was delivered to the customer by email facilitated through PerkinElmer Sales Team.Customers were requested to take the following actions until PerkinElmer's corrective measures are completed:
Inspect customer inventory of the 6000689 25 Clear Filter Pipette Tip and identify if
the affected lots are present. Complete and return the attached Response Form with the required information. Destroy all quantities of tips from the affected lots.
Upon receipt of the return Response Form, a shipment of replacement tips will be shipped. |
Quantity in Commerce |
595 trays (571,200 tips) |
Distribution |
Worldwide Distribution - US including CA, MA, NY, IA, OR , PA, WA and Internationally to Belgium, Canada, Finland, France, Germany, Japan, Netherlands, Singapore, and UK |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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