Recall Z-1140-2017
Siemens Healthcare Diagnostics, Inc. · initiated December 16, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: lots EB7180, FB7152, BA7194, EA7223, BA7250
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1140-2017
- Initiated
- December 16, 2016
- Terminated
- January 9, 2018
- Product code
- JIF – Enzymatic Method, Ammonia
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1141-2017 Class II | Dimension Vista Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in…Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex… | 12/16/2016Terminated |