Z-1296-2019 Class II Terminated
FDA device recall Z-1296-2019 was initiated by Abbott Laboratories, Inc on Aug 28, 2018 and is designated Class II. Reason for recall: There is a potential to generate falsely elevated serum or plasma chloride results when using the product. The recall status is terminated (terminated Sep 23, 2020). Affected quantity: 99 modules/kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- Aug 28, 2018
- Termination Date
- Sep 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 modules/kits
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.
Reason for Recall
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1296-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026