Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
FDA device recall Z-2965-2026 · posted 2026-08-14 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Products Ltd.
- Reason for recall
- Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
- Action taken
- 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).
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LIP
- Quantity affected
- 24 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, Kazakhst
- Date initiated
- 2026-07-13
- Date posted
- 2026-08-14
- Location
- Caernarfon, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM (K091361) | Siemens Healthcare Diagnostics | 2009-12-16 |