Skip to content
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.

Field note

Send feedback

We'll only use this to respond to your feedback.