Z-1885-2013Class II

IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T)...

Name: Z-1885-2013 IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T)...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2013-05-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-05-10 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid... on 2013-05-10. FDA classified it as Class II and gives the reason as "A rare variant of TSH, identified in a small cluster of patients, is not detected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1885-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-10
Posted: 2013-08-06
Terminated: 2016-05-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: A rare variant of TSH, identified in a small cluster of patients, is not detected.
Root cause tag: design
FDA root cause: Device Design
Action: On May 10, 2013, an Important Safety Information notice was sent to all affected Siemens Healthcare Diagnostic customers in the United States. On May 10, 2013, an Urgent Field Safety Notice was sent to all customers outside of the United States. These notices inform the customer that there is a rare variant of TSH, identified in a small cluster of patients that is not detected by some Siemens assays. This notice informs customers that they should continue to use the affected TSH assays as the observed rate of occurrence during a 30-month time period was 0.6 X 10 -7 and there are strong mitigating factors. These mitigating factors include co-interpretation of TSH results in conjunction with thyroxine and TS, patient history and clinical signs and symptoms. Although Siemens believes a look back is not required as the expected frequency of the variant is extremely rare, these notices state that this decision should be made by the medical director.
Quantity in commerce: 51792
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.
Product codes and lots: Per recall strategy.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1885-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1881-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1882-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1883-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1884-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1885-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06
Z-1886-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-06

Product code JLW

K940006Class IIImmulite Third Generation (Modification)Diagnostic Products Corp. / cleared 1994-12-19

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)