Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-0466-2019

Z-0466-2019 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Newark, DE

Recall Details

Product Type
Devices
Report Date
November 21, 2018
Initiation Date
September 7, 2018
Termination Date
November 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3956

Product Description

Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Lot Numbers: 18128BA, 18172BA, 18186BB

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