FDA Device recall Z-1141-2017
Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measur…
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measur… by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interv….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1141-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-16 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye s syndrome
Reason
Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.
Identifiers
| code_info | lots 16187BE, 16225BB and 16265AB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1141-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.