Z-1296-2019Class II

Abbott ARCHITECT cSystems ICT Module, REF 09D28-03

Name: Z-1296-2019 Abbott ARCHITECT cSystems ICT Module, REF 09D28-03
Creator: Abbott Laboratories, Inc
Published: 2018-08-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-08-28 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of... on 2018-08-28. FDA classified it as Class II and gives the reason as "There is a potential to generate falsely elevated serum or plasma chloride results when using the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1296-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-28
Posted: 2019-05-08
Terminated: 2020-09-23
Recalling firm: Abbott Medical
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.
Product code: CGZ Electrode, Ion-Specific, Chloride
Reason for recall: There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 99 modules/kits
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1296-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1296-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-08

Product code CGZ

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)