Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1708-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 20, 2015

Date Posted: June 10, 2015

Recall Number: Z-1708-2015

Event ID: 71096

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.

Status: Terminated

Product Quantity: 2256

Code Information:

Catalog Number K6412, Material Number 10445104, Lot Number 14237AA, exp. 2015-08-25.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated