Z-0780-2017Class II

PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED...

Name: Z-0780-2017 PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED...
Creator: PerkinElmer, Inc
Published: 2016-10-13
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2016-10-13 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer, Inc began a recall of PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001... on 2016-10-13. FDA classified it as Class II and gives the reason as "Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0780-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-13
Posted: 2016-12-16
Terminated: 2018-09-13
Recalling firm: Revvity Health Sciences, Inc.
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
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Lot Codes: 16091338, 16150558, 16091337, 16150559, 16160100, 16160099

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0780-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0780-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-16

Product code JQW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)