ARCHITECT recallZ-1296-2019 · Abbott Laboratories, Inc · initiated Aug 28, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
FDA root cause category: Under Investigation by firm
What the company is doing
The recalling firm issued letters dated 8/28/2018 via overnight mail. The letter explained the issue, patient impact, and instructed the consignee to immediately discontinue use of the product and destroy any remaining inventory of the impacted lot number. The letter was to be reviewed with the Medical Director and laboratory protocol should be followed regarding the need to review previously-reported patient results. A Customer Reply Form was enclosed for the U.S. consignees to indicate the consignee understood and completed the necessary actions to be taken. For questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
Recall details
- Recall number
- Z-1296-2019
- Status
- Terminated
- Initiated by the company
- Aug 28, 2018
- Recalling firm
- Abbott Laboratories, Inc
- Quantity
- 99 modules/kits
- Product code
- CGZ
- FDA submissions
- K980367
- 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.
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARCHITECT 9D28-03Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall15 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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