Recall Z-1629-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1629-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-09

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-04-09, terminated 2017-03-22. It names one FDA 510(k) clearance: K950072. Product: IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.. Reason: IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-09
Terminated: 2017-03-22
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K950072 — IMMULITE(R) TBGDiagnostic Products Corp.·cleared 1995-04-03

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

IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.

Reason for recall

IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values.

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