Data Foundry

Medical device recalls 2016

Perkin Elmer RoboRack 25ul — Class II medical device recall Z-0747-2017

Terminated recall by PerkinElmer, Inc, reported 2016-12-21, distributed in CA, IA, MA, NY, OR, PA, WA. Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspira

Recall numberZ-0747-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPerkinElmer, Inc, Hopkinton, MA, United States
Recall initiated2016-06-24
Classified2016-12-12
Reported by FDA2016-12-21
Terminated2018-07-31
DistributedCA, IA, MA, NY, OR, PA, WA
Countries outside the USBE, CA, DE, FI, FR, GB, JP, NL, SG
Reason classespackaging
Lot numbers15470394, 15471775, 1601067, 16071147
Model numbers6000689

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

Reason for recall

Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0747-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.