Z-1629-2015Class II

IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin...

Name: Z-1629-2015 IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-04-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-04-09 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and... on 2015-04-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1629-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-09
Posted: 2015-05-19
Terminated: 2017-03-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CEE Radioimmunoassay, Thyroxine-Binding Globulin
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.
FDA root cause: Unknown/Undetermined by firm
Action: Siemens sent an Urgent Field Safety 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. Actions to be Taken by the Customer Discontinue use and discard kit lot listed in Table 1. Review your inventory of these products to determine your laboratory's replacement needs. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions call (914) 631-8000.
Quantity in commerce: 155 kits
Distribution: Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.
Product codes and lots: LOT 0257, SMN 10381643

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1629-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1629-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-19

Product code CEE

K950072Class IImmulite(r) TbgDiagnostic Products Corp. / cleared 1995-04-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)