FDA Device recall Z-1884-2013
Dimension Vista System TSH Flex Reagent Cartridge (REF K6412)
- FDA Device
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of Dimension Vista System TSH Flex Reagent Cartridge (REF K6412) by Siemens Healthcare Diagnostics, citing A rare variant of TSH, identified in a small cluster of patients, is not detected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1884-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-10 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Reason
A rare variant of TSH, identified in a small cluster of patients, is not detected.
Identifiers
| code_info | Per recall strategy. |
|---|
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-1884-2013%22
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