Z-1887-2024Class II

IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody

Name: Z-1887-2024 IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-04-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-04-23 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody on 2024-04-23. FDA classified it as Class II and gives the reason as "The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1887-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-23
Posted: 2024-05-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
Product code: JZO System, Test, Thyroid Autoantibody
Reason for recall: The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.
FDA root cause: Under Investigation by firm
Action: On April23, 2024, Urgent Medical Device Correction letters were sent to customers. Customer Actions: 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Perform the following: Discontinue use of and discard the kit lots listed in the Products Table. You may request no-charge replacement product from your local Siemens Healthineers or distributor office. Please review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
Quantity in commerce: 488 units (33 US, 455 OUS)
Distribution: Worldwide - US Nationwide distribution including in the states of AL, CA, DC, FL, HI, ID, IN, KS, KY MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, PR, TX, WA WI and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Finland, France, Germany, Greece Guatemala, Honduras, Hong Kong, Hungary, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Norway, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Vietnam.
Product codes and lots: Catalog # L2KTG6, SMN 10381655, UDI/DI: 00630414962115, Lot #s: 785, 790, 791, 793.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1887-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1886-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-23
Z-1887-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-23

Product code JZO

K991094Class IIImmulite 2000 Anti-Tg Ab, Model L2ktg2, L2ktg6Diagnostic Products Corp. / cleared 1999-05-13

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)