Siemens Immulite 2000 Syphilis Screen Recall for Negative Bias
Siemens Healthineers is recalling 24 units of the Immulite 2000 Syphilis Screen assay due to a potential negative patient bias that may report low reactive results 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 is classified as FDA Class II and involves a diagnostic error (negative bias) that could lead to missed diagnoses of syphilis, a high-risk pathogen, without reported illnesses or injuries in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Products Ltd. is recalling 24 units of the Immulite 2000 Systems SYP Syphilis Screen assay (REF:L2KSY2(D)/10471981). The recall is classified as Class II by the U.S. Food and Drug Administration. The affected product is an in vitro diagnostic (IVD) device intended for prescription use only.
The recall is being issued because the assay may contain a negative patient bias. This defect can result in low reactive patient results being incorrectly reported as nonreactive. The specific lot code for the affected units is D387, and the UDI is 00630414976891.
The product was distributed worldwide, including nationwide distribution in the United States in the states of Florida, New Jersey, and New York. International distribution included Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Curaçao, Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, U.A.E., Ukraine, United Kingdom, and Uzbekistan. Healthcare providers and laboratories should stop using the affected units and contact the recalling firm for further instructions.
The recalled product
- Product
- Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Affected units
- 24
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 (1)
- Lot Code: D387/UDI: 00630414976891
Distribution
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