Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Summary
The FDA issued a Class II for Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/1 by Siemens Healthcare Diagnostics Products Ltd.. Reason: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive..
Details
Source
Device Recall
External ID
Z-2965-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Lot/Code Info: Lot Code: D387/UDI: 00630414976891
Quantity Affected: 24 units
Reason for Recall
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
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.¿¿¿¿¿
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-13
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Siemens Healthcare Diagnostics Products Ltd. has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics Products Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics Products Ltd. have FDA actions?
Siemens Healthcare Diagnostics Products Ltd. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2965-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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