Device product
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.
Z-0466-2019
Product summary
- Event
- Event 81237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3956
- Official record key
device-enforcement:Z-0466-2019
Official wording
Reason: There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Code information: Lot Numbers: 18128BA, 18172BA, 18186BB
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.
Derived failure modes
-
Unknown
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.