Siemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
Siemens Healthineers is recalling Immulite 2000 Syphilis Screen assays because a negative patient bias may cause low reactive results to be reported as nonreactive.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic test for a serious infectious disease where a defect could lead to false negative results. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific illnesses or injuries are reported in the source text, but the potential for missed diagnoses is significant.
Plain-English summary
Siemens Healthcare Diagnostics Products Ltd. is recalling 478 units of the Immulite 2000 Systems SYP Syphilis Screen assay. The recall involves specific reference numbers L2kSY2/10489085 and L2KSY6/10488319, with lot code D387 and associated UDI codes L2KSY2-00630414999791 and L2KSY6-00630414999807.
The recall was initiated because the assay may contain a negative patient bias. This defect can result in low reactive patient results being incorrectly reported as nonreactive, potentially leading to false negative diagnoses for syphilis.
The affected products were distributed worldwide, including nationwide distribution in the United States (specifically Florida, New Jersey, and New York) and in numerous international countries such as Austria, Belgium, Brazil, France, Germany, Italy, and the United Kingdom. Healthcare facilities and laboratories that purchased or received these specific lots should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Affected units
- 478
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: D387/UDI(s):L2KSY2-00630414999791
- L2KSY6 - 00630414999807
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics Products Ltd.
See all →- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
Same hazard · false negative
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighHeparin antibody test kits recalled over a defect producing negative results
FDA (Drugs) · 2026-01-21
- HighC. difficile assay recalled over declining performance and false negative results
FDA (Devices) · 2026-01-14
- HighFecal immunochemical tests recalled over the potential for false negative results
FDA (Devices) · 2025-12-10
Similar recalls
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- ModerateSiemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias
FDA (Devices) · 2014-05-07
- ModerateSiemens Recalls Intact PTH Assay Kits Due to Negative Bias
FDA (Devices) · 2017-01-18
- ModerateSiemens PSA Assay Kits Recalled for Positive Bias in Results
FDA (Devices) · 2013-09-04
- HighSiemens IMMULITE Thyroid Test Kit Recalled for Falsely Low Results
FDA (Devices) · 2022-10-05
- ModerateSiemens IMMULITE Total IgE Assay Recalled for Positive Bias
FDA (Devices) · 2014-05-07