FDA recall Z-1296-2019

Abbott Laboratories, Inc · Class II · 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.

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.

Key facts

Status
Terminated
Initiation date
2018-08-28
Report date
2019-05-15
Termination date
2020-09-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1296-2019