medical Class II Updated 2021-06-02

Siemens Healthcare Diagnostics, Inc recalls Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: Fo

Recalled 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


Hazard / Issue

Potential for the ADVIA Centaur Syphilis assay to carryover 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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots
View official government recall

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