Recall Z-2966-2026 · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Siemens Healthcare Diagnostics Products Ltd.
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
| Date | Aug 14, 2026 (initiated Jul 13, 2026) |
| Status | Open, Classified |
| Reason | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. |
| Root cause | Under Investigation by firm |
| Action | On July 13, 2026, Siemens Healthineers issued a Urgent Medical Device Correction to affected consignees via FedEx. Siemens asked consignees to take the following actions: 1. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2.Discontinue use and discard the affected kit lot. 3. Review your current inventory to determine your laboratory s replacement needs and provide this information to Siemens Healthineers for reporting to the authorities. 4. Complete and return the Field Correction Ef |
| Quantity | 478 units |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091361 | IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM Siemens Healthcare Diagnostics, Dec 16, 2009 |