Z-1140-2017Class II

Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for...

Name: Z-1140-2017 Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-12-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-12-16 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human... on 2016-12-16. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim due to reagent instability...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1140-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Posted: 2018-10-11
Terminated: 2018-01-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye s syndrome
Product code: JIF Enzymatic Method, Ammonia
Reason for recall: Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Siemens sent an Urgent Field Safety Notice on December 20, 2016, to all customers who were affected by the issue. The letter identified the reason for the correction, the associated risks to health, and actions to be taken by the customer. Customers were instructed to discontinue use of and discard the affected lots, complete and return the Field Correction Effectiveness Check Form attached to the letter. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 800441-9250.
Quantity in commerce: 11,165 units
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Bosnia Herzegovina. ,Canada, Canary Islands, Chile, China, Colombia, Croatia, Denmark, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary Israel ,India, Indonesia, Italy, Lebanon, Malaysia, Mexico, Nicaragua, Netherland, New Zealand, Philippines, Poland, Portugal, Republic of Korea, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Switzerland, Taiwan, Turkey, Uruguay, United.Arab Emirates, Venezuela, Yemen, and Japan.
Product codes and lots: lots EB7180, FB7152, BA7194, EA7223, BA7250

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1140-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-06
Z-1141-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-06

Product code JIF

K123320Class IDimension Ammonia Flex Reagent CartridgeSiemens Healthcare Diagnostics / cleared 2013-02-15

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)