Z-0465-2019Class II

Dimension Lipase Flex Reagent Cartridge, Model Number 10460277

Name: Z-0465-2019 Dimension Lipase Flex Reagent Cartridge, Model Number 10460277
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-09-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-09-07 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative... on 2018-09-07. FDA classified it as Class II and gives the reason as "There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0465-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-07
Posted: 2018-11-14
Terminated: 2020-11-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction letters dated 9/7/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
Quantity in commerce: 18396
Distribution: 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.
Product codes and lots: Lot Numbers: GD9002, GA9003, GB9032, GA9038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0465-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0465-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-14
Z-0466-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-21	2018-11-14

Product code CHI

K952816Class ILipase Flex Reagent CartridgeDupont Medical Products / cleared 1995-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)