Z-1668-2018Class II

Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge

Name: Z-1668-2018 Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-01-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-01-02 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge on 2018-01-02. FDA classified it as Class II and gives the reason as "The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1668-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-02
Posted: 2018-05-04
Terminated: 2023-02-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
Distribution: Nationwide and Canada, Mexico, and Thailand
Product codes and lots: TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1668-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1668-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1669-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1670-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1671-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1672-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1673-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1674-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1675-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1676-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1677-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1678-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1679-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1680-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1681-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1682-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1683-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1684-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1685-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1686-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1687-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1688-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1689-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1690-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1691-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code JLW

K140842Class IIDimension Loci Free Thyroxine Flex Reagent Cartridge, Ft4l, Dimension Loci Thyroid Stimulating Hormone Flex Reagent CartSiemens Healthcare Diagnostics, Inc. / cleared 2014-11-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)