Recall Z-2966-2026
Siemens Healthcare Diagnostics Products Ltd. · initiated July 13, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Codes / lots: Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
Reason for recall
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
FDA-determined cause: Under Investigation by firm
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).
Details
- Recall number
- Z-2966-2026
- Initiated
- July 13, 2026
- Posted by FDA
- August 14, 2026
- Product code
- LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- 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¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿
- Recalling firm
- Siemens Healthcare Diagnostics Products Ltd., Caernarfon
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2965-2026 Class II | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981…Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being… | 07/13/2026Open, Classified |