Z-1708-2015Class II

Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for...

Name: Z-1708-2015 Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-04-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-04-20 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating... on 2015-04-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1708-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-20
Posted: 2015-06-04
Terminated: 2016-12-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 2256
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 codes and lots: Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1708-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1708-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-04

Product code JLW

K140859Class IIDimension Vista Free Thyroxine Flex Reagent Cartridge, Ft4, Dimension Vista Thyroid Stimulating Hormone Flex ReagentSiemens Healthcare Diagnostics, Inc. / cleared 2014-11-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)