Device product
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.
Z-1296-2019
Product summary
- Event
- Event 81861
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 modules/kits
- Official record key
device-enforcement:Z-1296-2019
Official wording
Reason: There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Code information: Lot No. 180326, Exp. 12/26/2018; UDI (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399
Distribution pattern: 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.
Derived failure modes
-
Unknown
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.