Siemens Healthineers recallZ-2965-2026 · Siemens Healthcare Diagnostics Products Ltd. · initiated Jul 13, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Products Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
FDA root cause category: Under Investigation by firm
What the company is doing
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).
Recall details
- Recall number
- Z-2965-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 13, 2026
- Posted by the FDA
- Aug 14, 2026
- Recalling firm
- Siemens Healthcare Diagnostics Products Ltd.
- Quantity
- 24 units
- Product code
- LIP
- FDA submissions
- K091361
- 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 description
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Code information (models, lots, serial numbers)
Lot Code: D387/UDI: 00630414976891
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IMMULITE® 2000 Systems SYP Syphilis Screen 10471981Siemens Healthcare Diagnostics Products Ltd · ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99447).
- Z-2966-2026 · Open, ClassifiedSiemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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