CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen recalled
Siemens Healthcare Diagnostics Products is recalling Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen, distributed nationwide in the US. The recall was initiated on 13 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2965-2026
- FDA event ID
- 99447
- Recalling firm
- Siemens Healthcare Diagnostics Products, Caernarfon
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 13 Jul 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +32 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Where it was distributed
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.¿¿¿¿¿
Questions about this recall
Why was it recalled?
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
Which lots are affected?
Lot Code: D387/UDI: 00630414976891
Where was it sold?
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.¿¿¿¿¿
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99447This product is part of a recall event; the main page for the event is Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen recalled | Siemens Healthcare Diagnostics Products | Potency & Assay | Nationwide |
More recalls from Siemens Healthcare Diagnostics Products
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen recalled | Siemens Healthcare Diagnostics Products | Potency & Assay | Nationwide |
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