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U.S. Department of Health and Human Services

Class 2 Device Recall Pipette tips: Item Number: 6000689 25 L Clear Filter Sterile Roborack, Qty 960

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 Class 2 Device Recall Pipette tips: Item Number: 6000689 25 L Clear Filter Sterile Roborack, Qty 960see related information
Date Initiated by FirmJune 24, 2016
Create DateDecember 12, 2016
Recall Status1 Terminated 3 on July 31, 2018
Recall NumberZ-0747-2017
Recall Event ID 75508
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
ProductPerkin 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
FEI Number 3009981484
Recalling Firm/
Manufacturer		 PerkinElmer, Inc
68 Elm St
Hopkinton MA 01748-1602
For Additional Information Contact
508-435-9500
Manufacturer Reason
for Recall		Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
FDA Determined
Cause 2		Process control
ActionPerkinElmer 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 Commerce595 trays (571,200 tips)
DistributionWorldwide 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 CycleTPLC Device Report
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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