Recall Z-1580-2020— Abbott Gmbh & Co. KG
Class II · Terminated
Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2020-01-24, terminated 2023-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.. Reason: Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier..
- Recalling firm
- Abbott Gmbh & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-24
- Terminated
- 2023-08-08
- Firm location
- Wiesbaden, N/A, Germany
Product description
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
Reason for recall
Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
Data sourced from openFDA. This site is unofficial and independent of the FDA.