--- title: "Siemens Healthcare Diagnostics Products Ltd. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Siemens Healthcare Diagnostics Products Ltd. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/siemens-healthcare-diagnostics-products-ltd/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Siemens Healthcare Diagnostics Products Ltd. recall records **2** reported ongoing 2 records in this archive. Latest source date Jul 13, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 13, 2026 FDA device enforcement ### [Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly](https://isitonrecall.com/recall/fda-device-z-2965-2026-siemens-healthineers-immulite-2000-systems-syp-syphilis-screen-ref-l2ksy2-d-10471981-ivd-rxonly/) Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. Class II Reported ongoing 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, G... [Official source for Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2965-2026%22) Jul 13, 2026 FDA device enforcement ### [Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly](https://isitonrecall.com/recall/fda-device-z-2966-2026-siemens-healthineers-immulite-2000-systems-syp-syphilis-screen-ref-s-l2ksy2-10489085-l2ksy6-10488319/) Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. Class II Reported ongoing 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, G... [Official source for Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/104...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2966-2026%22) ## Reasons in these listed records - Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. These examples come from this result page and are not a ranking of every recall reason. ## Checking Siemens Healthcare Diagnostics Products Ltd. ### Is there a recall on siemens healthcare diagnostics products ltd. right now? This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Siemens Healthcare Diagnostics Products Ltd.](https://isitonrecall.com/check/?q=Siemens%20Healthcare%20Diagnostics%20Products%20Ltd.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)