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Recall Observatory FDA recall evidence

Device 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.

Z-0465-2019

September 07, 2018

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 81237
Status
Terminated
Classification
Class II
Quantity
18396
Official record key
device-enforcement:Z-0465-2019

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: GD9002, GA9003, GB9032, GA9038

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

    reason.no_named_rule · v1.0.0

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