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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen

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 Class 2 Device Recall Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screensee related information
Date Initiated by FirmJuly 13, 2026
Date PostedAugust 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2966-2026
Recall Event ID 99447
510(K)NumberK091361 
Product Classification Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
ProductSiemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Code Information Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
FEI Number 3002806944
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Caernarfon United Kingdom
For Additional Information ContactLouise Mclaughlin
+441286-879405
Manufacturer 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 2		Under Investigation by firm
ActionOn 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).
Quantity in Commerce478 units
DistributionWorldwide - 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.¿¿¿¿¿
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LIP
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