Recall Z-0543-2020— Abbott Gmbh & Co. KG

Name: FDA recall Z-0543-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-16

Class II · Ongoing

Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2019-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity ci Level Sensor, Bulk Solution. Reason: Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks..

Recalling firm: Abbott Gmbh & Co. KG
Classification: Class II
Status: Ongoing
Initiated: 2019-09-16
Firm location: Wiesbaden, Germany

Product description

Alinity ci Level Sensor, Bulk Solution

Reason for recall

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

Data sourced from openFDA. This site is unofficial and independent of the FDA.