CLASS II Device recall · Reported 15 May 2019 · FDA Enforcement Report

Abbott Architect cSystems ICT Module recalled by Abbott Laboratories

Abbott Laboratories is recalling Abbott Architect cSystems ICT Module, distributed nationwide in the US. The recall was initiated on 28 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 180326, Exp. 12/26/2018; UDI (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399

Quantity recalled99 modules/kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1296-2019
FDA event ID: 81861
Recalling firm: Abbott Laboratories, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 28 Aug 2018
FDA classified: 8 May 2019
Reported: 15 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

28 Aug 2018	Recall initiated by company
8 May 2019	Classified by FDA	+253 days
15 May 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas California Connecticut Florida Iowa Indiana Louisiana Massachusetts Maryland Mississippi New Jersey New York Pennsylvania South Carolina Texas Vermont Washington West Virginia

Questions about this recall

Is Abbott Architect cSystems ICT Module recalled?

Yes. Abbott Laboratories recalled Abbott Architect cSystems ICT Module on 28 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-1296-2019.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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