FDA Device recall Z-1296-2019
Abbott ARCHITECT cSystems ICT Module, REF 09D28-03
- FDA Device
- Class II
- terminated
- Published 2019-05-15
On 2019-05-15 the FDA classified a Class II recall of Abbott ARCHITECT cSystems ICT Module, REF 09D28-03 by Abbott Laboratories, citing there is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1296-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-28 |
| Published | 2019-05-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
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
There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1296-2019%22
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