FDA recall Z-1674-2021

Siemens Healthcare Diagnostics, Inc · Class II · device

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Burkina Faso, Croatia, Czech Republic, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Germany, Greece, Guadeloupe, Italy, Kazakhstan, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Russian Fed., Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., Ukraine, United Kingdom.

Key facts

Status
Ongoing
Initiation date
2021-04-21
Report date
2021-06-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Walpole, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1674-2021