Abbott Laboratories, Inc recalls Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Techn

Recalled May 15, 2019 · FDA recall Z-1296-2019 · Abbott Laboratories

Hazard

There is a potential to generate falsely elevated serum or plasma chloride results when using the product. · FDA Class II

Units

99 modules/kits

Sold at

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.

Description

There is a potential to generate falsely elevated serum or plasma chloride results when using the product.

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.

Manufacturer(s)

Abbott Laboratories, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →