Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1629-2015)

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:

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.

Product Classification:

Class II

Date Initiated: April 9, 2015

Date Posted: May 27, 2015

Recall Number: Z-1629-2015

Event ID: 71006

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.

Status: Terminated

Product Quantity: 155 kits

Code Information:

LOT 0257, SMN 10381643

Distribution Pattern:

Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.

Voluntary or Mandated:

Voluntary: Firm initiated