Recall Z-2401-2020— Abbott Gmbh & Co. KG
Class II · Terminated
Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2020-05-12, terminated 2023-01-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.. Reason: There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase..
- Recalling firm
- Abbott Gmbh & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-12
- Terminated
- 2023-01-31
- Firm location
- Wiesbaden, Germany
Product description
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Reason for recall
There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
Data sourced from openFDA. This site is unofficial and independent of the FDA.