Recall Z-0747-2017
PerkinElmer, Inc · initiated June 24, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Numbers:15470394, 15471775, 1601067, 16071147
Reason for recall
Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0747-2017
- Initiated
- June 24, 2016
- Terminated
- July 31, 2018
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- Quantity
- 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
- Recalling firm
- PerkinElmer, Inc, Hopkinton, MA