Siemens Healthcare Diagnostics, Inc Recall 87770
Description: 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
Siemens Healthcare Diagnostics, Inc Recall 87770 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1674-2021 |
| Event ID | 87770 |
| Event Description | 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 |
| Product Type | Devices |
| 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. |
| Quantity | 22550 units |
| Recall Reason | 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 |
| Device Classification | 20210602 |
| Device Code Info | All Lots |
| Center Classification Date | 20210524 |
| Recall Initiation Date | 20210421 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc |
| Initial Notification | Letter |
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