Recall Z-2701-2020— Abbott Gmbh & Co. KG
Class II · Terminated
Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2020-06-19, terminated 2024-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below. Reason: Quality Control results were not properly evaluated for QC failures..
- Recalling firm
- Abbott Gmbh & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-19
- Terminated
- 2024-04-10
- Firm location
- Wiesbaden, N/A, Germany
Product description
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Reason for recall
Quality Control results were not properly evaluated for QC failures.
Data sourced from openFDA. This site is unofficial and independent of the FDA.