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Terminated

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

FDA Recall Z-1140-2017 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJIF
Date Initiated2016-12-16
Date Terminated2018-01-09
Product Quantity11,165 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics · 2013-02-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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