Fresh Recalls

FDAClass II · Medical device · Recall Z-2966-2026 · Recalled August 26, 2026

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s) recall — Siemens Healthcare Diagnostics Products Ltd.

Agency report date: August 26, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s)
Company / brand
Siemens Healthcare Diagnostics Products
Lot / serial / date codes
Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
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.¿¿¿¿¿
Agency product description and boundaries

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s) recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2966-2026
Brand
All Siemens Healthcare Diagnostics Products recalls
Classification
Class II
Units affected
478 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Caernarfon, United Kingdom
Firm address
Glyn Rhonwy, N/A

Identifying details (verbatim from the notice)

Product codes / lots
Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
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.¿¿¿¿¿
Firm notified the public via
Letter
FDA event ID
99447
Recall initiated
July 13, 2026
FDA classified
August 14, 2026
FDA report date
August 26, 2026

Other medical device recalls from around the same time

Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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