Siemens Centaur Syphilis Assay Recalled for Potential Carryover Interference
Siemens Healthcare Diagnostics is recalling the Centaur Syphilis Assay-SYP Kit due to potential carryover into other assays on specific systems.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential carryover effect that only occurs under specific sequencing conditions, and no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Centaur Syphilis Assay-SYP Kit, 200 Test. The recall involves 22,550 units distributed worldwide, including the United States and numerous international locations. The product is used for in vitro diagnostic testing to determine antibodies to Treponema pallidum in human serum or plasma.
The recall is issued because of the potential for the assay to carry over into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems.
The source text does not specify a particular action for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 22,550
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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