FDA Device recall Z-1991-2014
ADVIA Centaur¿ Systems TnI-Ultra assay
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of ADVIA Centaur¿ Systems TnI-Ultra assay by Siemens Healthcare Diagnostics, citing the solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1991-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-30 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
Reason
The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
Identifiers
| code_info | Kit Lots Ending In: 078, 079, 082, 083, 084 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1991-2014%22
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