Abbott recalls ARCHITECT cSystems ICT Module REF 09D28-03 for potential false elevated chloride test results. Affected units may give inaccurate blood chloride readings.
“Abbott ARCHITECT cSystems ICT Module: False Chloride Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69957-abbott-architect-csystems-ict-module-false-chloride-results-risk. Based on FDA recall #Z-1296-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1296-2019%22&limit=1).
The FDA announced on 2018-08-28 that Abbott Laboratories, Inc. is recalling its ARCHITECT cSystems ICT Module due to a potential for generating falsely elevated serum or plasma chloride results. The agency issued recall number Z-1296-2019 for the voluntary Class II action.
UDI (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399
The hazard
According to the FDA, there is a potential to generate falsely elevated serum or plasma chloride results when using the product. The ARCHITECT cSystems ICT is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
Context
GovInfoNow's records show Abbott Laboratories, Inc. has 11 other recalls on record since 2017-09-29. Other recent recalls include the Abbott Alinity s System Software Version 2.8.0 Recall (2022-02-03), the Abbott Alinity s System Recall (2021-07-12), and the Abbott ARCHITECT C System Mixer Recall (2019-05-01). Other recent recalls of similar products include the Siemens Atellica CH Urine Albumin Recall (2026-07-06) and the Siemens Atellica CH A1c_E Test Recall (2026-06-08).
How to tell if you have this one
Look for the product name 'ARCHITECT cSystems ICT Module' with serial number REF 09D28-03. Units were sold with lot numbers starting from 180326 through 180326399.
Verify chloride test results with a different method if possible to confirm accuracy.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Connecticut, Florida, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Mississippi, New Jersey, New York, Pennsylvania, South Carolina, Texas, Vermont, Washington, West Virginia.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1296-2019 (August 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1296-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
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