FDA · Medical devices ·
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly recall
Siemens Healthcare Diagnostics Products Ltd. recalled Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly on August 26, 2026 because of syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. It was sold nationwide.
Why it was recalled
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
What's recalled
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Quantity: 24 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Siemens Healthcare Diagnostics Products Ltd., Caernarfon
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
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¿… - Status
- Ongoing
- Recall number
- Z-2965-2026
- Source
- U.S. Food and Drug Administration
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