Abbott Gmbh & Co. KG recalls Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system…

Recall date

April 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1709-2019

FDA classification

Class II

Brand / firm

Abbott Gmbh & Co. KG

Sold / distributed

US Nationwide Distribution- AL, AR,CA, FL, GA, IL, LA, MA, ME, MN, MO, NJ, NY, OK, SC, TN, TX, UT, & VA WORLDWIDE - Albania, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.