Recall Z-1708-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1708-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-20

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-04-20, terminated 2016-12-13. It names one FDA 510(k) clearance: K140859. 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-20
Terminated: 2016-12-13
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K140859 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENTSiemens Healthcare Diagnostics, Inc.·cleared 2014-11-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.