Siemens Healthcare Diagnostics Products recall: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD and 1 more product
Siemens Healthcare Diagnostics Products Ltd. is recalling Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD and 1 more product – 24 units; 478 units. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 13, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD and 1 more product |
| Brand | Siemens Healthcare Diagnostics Products |
| Company | Siemens Healthcare Diagnostics Products Ltd. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 13, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 24 units; 478 units |
| Recall ID | 99447 |
Recalled products (2)
- Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
- FDA recall number
- Z-2965-2026
- Codes, lots and dates
- Lot Code: D387/UDI: 00630414976891
- Quantity
- 24 units
- Classification
- Class II
- Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
- FDA recall number
- Z-2966-2026
- Codes, lots and dates
- Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
- Quantity
- 478 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99447
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Caernarfon, United Kingdom
Why it was recalled
The reason the FDA lists: “Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.¿¿¿¿¿”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99447, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Siemens Healthcare Diagnostics Products Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD recalled?
Yes. Siemens Healthcare Diagnostics Products Ltd. recalled it on July 13, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.