FDA-Device2019-05-15Class II
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
Abbott Laboratories, Inc
Hazard
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Sold states
Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS, NJ, NY, PA, SC, TX, VT, WA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Australia, China, Hong Kong, and New Zealand.
Affected count
99 modules/kits
Manufactured in
1921 Hurd Dr, N/A, Irving, TX, United States
Products
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1296-2019Don't want to check this manually?
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