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U.S. Department of Health and Human Services

Class 2 Device Recall PerkinElmer 20ul Clear RoboRack Tip, Pipette

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 Class 2 Device Recall PerkinElmer 20ul Clear RoboRack Tip, Pipettesee related information
Date Initiated by FirmOctober 13, 2016
Create DateDecember 16, 2016
Recall Status1 Terminated 3 on September 13, 2018
Recall NumberZ-0780-2017
Recall Event ID 75588
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
ProductPerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS EXPRESS Product Codes: AJS4NGS
Code Information Lot Codes: 16091338, 16150558, 16091337, 16150559, 16160100, 16160099
FEI Number 3009981484
Recalling Firm/
Manufacturer		 PerkinElmer, Inc
68 Elm St
Hopkinton MA 01748-1602
For Additional Information ContactSAME
508-435-9500
Manufacturer Reason
for Recall		Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.
FDA Determined
Cause 2		Process control
ActionPerkinElmer initiated the recall on Sept 1. 2016 by letter dated . Customers were told of the defect, potential for inaccurate measurements, and requested to inspect for the lots stop using and destroy. Replacement product to be provided. Accounts asked to compelte Response form. Questions call your PerkinElmer representative.
Quantity in Commerce33312
DistributionIA, MD, NY, WA Foreign: France, Germany, The Netherlands, Hungary, Singapore
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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