Z-2965-2026Class II

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Name: Z-2965-2026 Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Creator: Siemens Healthcare Diagnostics Products Ltd.
Published: 2026-07-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Products Limited / initiated 2026-07-13 / Open, Classified

FDA source

Siemens Healthcare Diagnostics Products Ltd. began a recall of Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly on 2026-07-13. FDA classified it as Class II and gives the reason as "Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2965-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-13
Posted: 2026-08-14
Recalling firm: Siemens Healthcare Diagnostics Products Limited
Product: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
FDA root cause: Under Investigation by firm
Action: On July 13, 2026, Siemens Healthineers issued a Urgent Medical Device Correction to affected consignees via FedEx. Siemens asked consignees to take the following actions: 1. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2.Discontinue use and discard the affected kit lot. 3. Review your current inventory to determine your laboratory s replacement needs and provide this information to Siemens Healthineers for reporting to the authorities. 4. Complete and return the Field Correction Effectiveness Check Form attached to this letter within (30) days. 5.Retain this letter with your laboratory records and forward this letter to those who may have received the affected product(s).
Quantity in commerce: 24 units
Distribution: Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿
Product codes and lots: Lot Code: D387/UDI: 00630414976891

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2965-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2965-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14
Z-2966-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code LIP

K091361Class IIImmulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics / cleared 2009-12-16

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)