CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Immulite 2000 PSA assay recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Immulite 2000 PSA assay, distributed nationwide in the US. The recall was initiated on 30 Sep 2024 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-0464-2025
- FDA event ID
- 95513
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2024
- FDA classified
- 14 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Sep 2024 | Recall initiated by company | |
| 14 Nov 2024 | Classified by FDA | +45 days |
| 20 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
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
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is Immulite 2000 PSA assay recalled?
Yes. Siemens Healthcare Diagnostics recalled Immulite 2000 PSA assay on 30 Sep 2024. The recall is Class II and its status is Ongoing. Recall number Z-0464-2025.
Why was it recalled?
The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
Which lots are affected?
SMN 10706281: UDI - 00630414982212, Lot Number D164; SMN 10706282: UDI - 00630414982229, Lot Number D166; SMN 10380896 (OUS): UDI - 00630414961958; SMN 10380996 (OUS): UDI - 00630414961965; OUS Lot Numbers: 438, 439, 440
Where was it sold?
Worldwide - US Nationwide distribution.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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