Recall Z-0710-2022— Abbott Molecular, Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2022-02-11, terminated 2023-04-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity m Integrated Reaction Units (IRU). Reason: There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-02-11
- Terminated
- 2023-04-14
- Firm location
- Des Plaines, IL, United States
Product description
Alinity m Integrated Reaction Units (IRU)
Reason for recall
There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Data sourced from openFDA. This site is unofficial and independent of the FDA.