FDA Device recall Z-1708-2015
Dimension Vista Systems LOCI Thyroid Stimulating Hormone
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Dimension Vista Systems LOCI Thyroid Stimulating Hormone by Siemens Healthcare Diagnostics, citing dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1708-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-20 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista System.
Reason
Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well.
Identifiers
| code_info | Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25. |
|---|
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-1708-2015%22
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