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.
Check against the official notice below — it lists the full affected range.
Abbott Laboratories is recalling 99 ARCHITECT cSystems ICT Module units (Lot No. 180326, expiring 12/26/2018) used for measuring sodium, potassium, and chloride levels in blood samples. The modules can produce falsely elevated serum or plasma chloride results. The affected units were distributed nationwide across 18 U.S. states and internationally to Australia, China, Hong Kong, and New Zealand.
The recall source does not specify a remedy or what consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Reason for recall: There is a potential to generate falsely elevated serum or plasma chloride results when using the product. Distribution: 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. Quantity: 99 modules/kits Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.