FDA Device recall Z-1657-2014
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021
- FDA Device
- Class II
- terminated
- Published 2014-06-04
On 2014-06-04 the FDA classified a Class II recall of ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021 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-1657-2014 |
| 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 VitD 500 test, Ready Pack, Catalog Number: 10631021. 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: 023 07J uly 2014 024 08 September 2014 025 08 December 2014 026 09 February 2015 027 10 April 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-1657-2014%22
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