Recall Z-1151-2018— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2018-01-18, terminated 2023-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.. Reason: A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-18
- Terminated
- 2023-09-27
- Firm location
- Brea, CA, United States
Product description
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
Reason for recall
A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips.
Data sourced from openFDA. This site is unofficial and independent of the FDA.