Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagn...
FDA Recall #Z-1140-2017 — Class II — December 16, 2016
Product Description
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
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Newark, DE
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
lots EB7180, FB7152, BA7194, EA7223, BA7250
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated