Class II — Abbott Laboratories, Inc
| Recalling firm | ABBOTT LABORATORIES |
|---|---|
| Registered facility | View this company's 64 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential to generate falsely elevated serum or plasma chloride results when using the product. |
| 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. |
| Quantity | 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. |
| Initiated | 2018-08-28 |
| Classified | 2019-05-08 |
| Terminated | 2020-09-23 |
| Recall number | Z-1296-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Abbott Laboratories, Inc (Z-1296-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81861/
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