Abbott ARCHITECT cSystems ICT Module — Class II medical device recall Z-1296-2019
Terminated recall by Abbott Laboratories, Inc, reported 2019-05-15, distributed nationwide. There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
| Recall number | Z-1296-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Inc, Irving, TX, United States |
| Recall initiated | 2018-08-28 |
| Classified | 2019-05-08 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2020-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, HK, NZ |
| Quantity | 99 modules |
| UPC / GTIN / UDI-DI | 00380740019327 |
| Lot numbers | 180326 |
| Model numbers | 09D28-03 |
| Expiration dates | 2018-12-26 |
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.
Reason for recall
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1296-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.