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Class 2 Device Recall PerkinElmer 20ul Clear RoboRack Tip, Pipette |
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Date Initiated by Firm |
October 13, 2016 |
Create Date |
December 16, 2016 |
Recall Status1 |
Terminated 3 on September 13, 2018 |
Recall Number |
Z-0780-2017 |
Recall Event ID |
75588 |
Product Classification |
Station, pipetting and diluting, for clinical use - Product Code JQW
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Product |
PerkinElmer 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 |
Recalling Firm/ Manufacturer |
PerkinElmer, Inc 68 Elm St Hopkinton MA 01748-1602
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For Additional Information Contact |
SAME 508-435-9500
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Manufacturer Reason for Recall |
Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.
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FDA Determined Cause 2 |
Process control |
Action |
PerkinElmer 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 Commerce |
33312 |
Distribution |
IA, MD, NY, WA
Foreign: France, Germany, The Netherlands, Hungary, Singapore |
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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