Z-1820-2022Class II

IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN)...

Name: Z-1820-2022 IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN)...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-08-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-08-11 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS) on 2022-08-11. FDA classified it as Class II and gives the reason as "An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1820-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-11
Posted: 2022-09-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
Product code: JZO System, Test, Thyroid Autoantibody
Reason for recall: An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid
FDA root cause: Under Investigation by firm
Action: Siemens Healthcare issued an "Urgent Medical Device Correction (UMDC IMC 22-09.A.US)" to US customers, and an "Urgent Field Safety Notice (UFSN IMC 22-09.A.OUS)" to Outside the US (OUS) customers. The UMDC and UFSN letters provide instructions to customers to follow: When this issue occurs, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid. Mitigations would include correlation of tests results with additional tests such as anti-TPO antibodies along with thyroid function tests such as total T3 and T4, free T3 and T4 and TSH results. A review of previously generated results is not recommended as results would not be used in isolation. Actions to be Taken by the Customer: Please review this letter with your Medical Director. Discontinue use of and discard the Kit Lot listed in Table 1. Review your inventory of this product to determine your laboratory's replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days via email to: [email protected] Or to fax this completed form to the Customer Care Center at: (312) 275-7795 If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, contact your local Siemens Healthineers technical support representative or call 508-668-5000.
Quantity in commerce: 100 units US; 328 units OUS
Distribution: Worldwide Distribution: US (nationwide) to states of: FL IN MA MI NH NJ NY OH TX UT and OUS (Foreign) countries of: Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ P.R.¿China¿¿¿¿¿ Singapore¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿
Product codes and lots: UDI-DI: (01)00630414597188(10)D389S(17)221130 (US); (01)00630414597171(10)389(17)221130 (OUS) Lot Number: 389 Exp.Date: 2022-11-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1820-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1820-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-27

Product code JZO

K152061Class IIIMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. / cleared 2016-03-03

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)