Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

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 Effectiveness Check Form attached to this letter within (30) days. 5.Retain this letter with your laboratory records and forward this letter to those who may have received the affected product(s).