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.
What this means for you
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
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