Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM recall
Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of…
Why was Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM recalled?
Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lots 16187BE, 16225BB and 16265AB
- Product
- Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 8,032 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.
- Recall date
- February 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)