Recall Z-0780-2017— PerkinElmer, Inc
Class II · Terminated
Class II FDA medical device recall by PerkinElmer, Inc, initiated 2016-10-13, terminated 2018-09-13. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips..
- Recalling firm
- PerkinElmer, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-13
- Terminated
- 2018-09-13
- Firm location
- Hopkinton, MA, United States
Product description
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
Reason for recall
Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.
Data sourced from openFDA. This site is unofficial and independent of the FDA.