Dimension Vista Systems LOCI Thyroid Stimulating Hormone recallZ-1708-2015 · Siemens Healthcare Diagnostics, Inc. · initiated Apr 20, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Siemens sent an Urgent Medical Device Recall notice, dated April 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. - Review this letter with your Medical Doctor. - Discontinue use and discard your remaining inventory of the reagent lot listed in Table 1. - Indicate your replacement product needs on the attached Field Correction Effectiveness Check form and fax to (312) 275-7795 within 30 days. Siemens will replace any unused inventory of the affected lot at no charge. We apologize for the inconvenience this situation may cause.. If you have any questions, please contact your Siemens Customer Care Center Technical Solutions at 800-441-9258, or your local Siemens technical support representative.
Recall details
- Recall number
- Z-1708-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 20, 2015
- Posted by the FDA
- Jun 4, 2015
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 2256
- Product code
- JLW
- FDA submissions
- K140859
- Distribution
- Worldwide Distribution - Nationwide and to the countries of : Australia, Japan, New Zealand, Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Netherlands, Portugal, and Slovakia.
Product description
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.
Code information (models, lots, serial numbers)
Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25.
Other devices under the same FDA submission
2 devices cleared under K140859 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® Flex® reagent cartridge TSH 10445104Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE19 reports
- Dimension Vista® Flex® reagent cartridge FT4 10445103Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, FREE THYROXINE13 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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