Recall Z-0780-2017 ยท JQW Station, Pipetting And Diluting, For Clinical Use
PerkinElmer, Inc
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
| Date | Oct 13, 2016 |
| Status | Terminated |
| Reason | Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips. |
| 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 | 33312 |
| Distribution | IA, MD, NY, WA Foreign: France, Germany, The Netherlands, Hungary, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.