Siemens Healthcare Diagnostics, Inc. recalls Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitr…

Recall date

September 7, 2018

Source

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

Recall number

Z-0465-2019

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide - US Nationwide Distributions The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, Peru,…

Why it was recalled

There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.

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

What was recalled

Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.