Recall Z-0780-2017

PerkinElmer, Inc · initiated October 13, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / lots: Lot Codes: 16091338, 16150558, 16091337, 16150559, 16160100, 16160099

Reason for recall

Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.

FDA-determined cause: Process control

Action taken

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.

Details

Recall number
Z-0780-2017
Initiated
October 13, 2016
Terminated
September 13, 2018
Product code
JQW – Station, Pipetting And Diluting, For Clinical Use
Quantity
33312
Distribution
IA, MD, NY, WA Foreign: France, Germany, The Netherlands, Hungary, Singapore
Recalling firm
PerkinElmer, Inc, Hopkinton, MA

Official FDA recall record