Recall Z-1709-2019— Abbott Gmbh & Co. KG
Class II · Terminated
Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2019-04-15, terminated 2020-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.. Reason: Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom..
- Recalling firm
- Abbott Gmbh & Co. KG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-15
- Terminated
- 2020-10-13
- Firm location
- Wiesbaden, Germany
Product description
Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.
Reason for recall
Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.
Data sourced from openFDA. This site is unofficial and independent of the FDA.