Recall Z-1674-2021 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Siemens Healthcare Diagnostics, Inc
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
| Date | Apr 21, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Device Design |
| Action | Siemens issued Urgent Medical Device Correction (UMDC) to US affected customers via FedEx beginning on 04/21/2021. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 04/21/2021. Letter states reason for recall, health risk and Actions to be Taken by the Customer: Please review this letter with your Medical Director. If you have multiple ADVIA Centaur XP/XPT or ADVIA Centaur CP systems: Siemens recommends testing the ADVIA Centaur Syphilis assa |
| Quantity | 22550 units |
| 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 Fe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112343 | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS Siemens Healthcare Diagnostics, Inc., Jan 20, 2012 |