Z-0747-2017Class II

Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied...

Name: Z-0747-2017 Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied...
Creator: PerkinElmer, Inc
Published: 2016-06-24
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2016-06-24 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer, Inc began a recall of Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations... on 2016-06-24. FDA classified it as Class II and gives the reason as "Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing". 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-0747-2017
Classification: Class II
Status: Terminated
Initiated: 2016-06-24
Posted: 2016-12-12
Terminated: 2018-07-31
Recalling firm: Revvity Health Sciences, Inc.
Product: Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 , AJL4M01, AJM8M01, AJI8M01, AJL8M01, AGS4NGS The JANUS Automated Workstation is an automated, programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows. The NGS Express is an automated, programmable liquid handling instrument suitable for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation workflows
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
Root cause tag: manufacturing process
FDA root cause: Process control
Action: PerkinElmer initiated recall on June 24, 2016 to the Product Manager and was delivered to the customer by email facilitated through PerkinElmer Sales Team.Customers were requested to take the following actions until PerkinElmer's corrective measures are completed: Inspect customer inventory of the 6000689 25 Clear Filter Pipette Tip and identify if the affected lots are present. Complete and return the attached Response Form with the required information. Destroy all quantities of tips from the affected lots. Upon receipt of the return Response Form, a shipment of replacement tips will be shipped.
Quantity in commerce: 595 trays (571,200 tips)
Distribution: Worldwide Distribution - US including CA, MA, NY, IA, OR , PA, WA and Internationally to Belgium, Canada, Finland, France, Germany, Japan, Netherlands, Singapore, and UK
Product codes and lots: Lot Numbers:15470394, 15471775, 1601067, 16071147

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0747-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0747-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12

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)