Recall Z-0544-2020— Abbott Gmbh & Co. KG
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: Accessory kit, Alinity i containing 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
Accessory kit, Alinity i containing 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.