Abbott Laboratories, Inc: Medical Device Recall in 2019 - (Recall #: Z-1296-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 28, 2018

Date Posted: May 15, 2019

Recall Number: Z-1296-2019

Event ID: 81861

Reason for Recall:

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

Status: Terminated

Product Quantity: 99 modules/kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated