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Recall Observatory FDA recall evidence

Device 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

Z-0780-2017

October 13, 2016

Class II

Product summary

Firm
PerkinElmer, Inc
Event
Event 75588
Status
Terminated
Classification
Class II
Quantity
33312
Official record key
device-enforcement:Z-0780-2017

Official wording

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

Code information: Lot Codes: 16091338, 16150558, 16091337, 16150559, 16160100, 16160099

Distribution pattern: IA, MD, NY, WA Foreign: France, Germany, The Netherlands, Hungary, Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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