Z-1296-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- August 28, 2018
- Termination Date
- September 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 modules/kits
Product Description
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.
Reason for Recall
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
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.
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