FDA Device recall Z-1655-2014
ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625
- FDA Device
- Class II
- terminated
- Published 2014-06-04
On 2014-06-04 the FDA classified a Class II recall of ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625 by Siemens Healthcare Diagnostics, citing samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1655-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-10 |
| Published | 2014-06-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Reason
Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
Identifiers
| code_info | Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 201…Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015 |
|---|
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-1655-2014%22
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