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

Recalled November 21, 2018 · FDA recall Z-0465-2019 · Siemens Healthcare Diagnostics

Hazard

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

Units

18396

Sold at

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, Philippines, Paraguay, El Salvador, Thailand, Taiwan, Uruguay and South Africa, Austria, Bahamas, Belgium, Czech Republic, Denmark, , France, , Italy, Netherland, Norway , Portugal, Kuwait, Slovenia, Spain, Switzerland, United Kingdom, Qatar, Republic of Korea, Saudi Arabia, Slovakia, Algeria, Bahrain, Bulgaria, Egypt, , Hungary, Latvia, Lebanon, Lithuania, Macedonia, Nepal, Poland, Romania, Russia Fed, Serbia, Turkey, U.A.E, United Kingdom.

Description

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

Product

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.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →