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Recall Observatory FDA recall evidence

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

August 28, 2018

Class II

Product summary

Firm
Abbott Laboratories, Inc
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

    reason.no_named_rule · v1.0.0

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