Z-2965-2026 Class II Ongoing
FDA device recall Z-2965-2026 was initiated by Siemens Healthcare Diagnostics Products Ltd. on July 13, 2026 and is designated Class II. Reason for recall: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. The recall status is ongoing. Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2026
- Initiation Date
- July 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Reason for Recall
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Distribution Pattern
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.¿¿¿¿¿
Code Information
Lot Code: D387/UDI: 00630414976891