Dimension Vista Systems LOCI Thyroid Stimulating Hormone — Class II medical device recall Z-1708-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-06-10, distributed nationwide. Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results rangi
| Recall number | Z-1708-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2015-04-20 |
| Classified | 2015-06-04 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, ES, FI, FR, GB, IT, JP, NL, NZ, PT, SK |
| Quantity | 2,256 |
| Lot numbers | 14237AA |
| Model numbers | K6412 |
| Expiration dates | 2015-08-25 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1708-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.