Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-1674-2021

U.S. FDA — Device Enforcement · United States · 2021-04-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1674-2021
Date of alert
2021-04-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10492493
Reported risk: 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
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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