IMMULITE 2000 Systems PTS PSA recallZ-0464-2025 · Siemens Healthcare Diagnostics, Inc. · initiated Sep 30, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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).
FDA root cause category: Under Investigation by firm
What the company is doing
An Urgent Medical Device Correction letter dated 9/30/24 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, that may have been affected. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution IMMULITE 2000 and IMMULITE 2000 XPi kit lots D168 and above meet the IFU high-dose hook effect claim. Siemens continues to investigate root cause of the issue observed with the impacted kit lots. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please send a scanned copy of the completed form via email to [email protected]. Or to fax this completed form to the Customer Care Center at (312) 275-7795.
Recall details
- Recall number
- Z-0464-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 30, 2024
- Posted by the FDA
- Nov 14, 2024
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 7,332 units
- Product code
- MTF
- FDA submissions
- P930027
- Distribution
- Worldwide - US Nationwide distribution.
Product description
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- IMMULITE® 2000 Systems PTS PSA 10706281Siemens Healthcare Diagnostics Products Ltd · Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer1 recall1 report
- IMMULITE® 2000 Systems PTS PSA 10706282Siemens Healthcare Diagnostics Products Ltd · Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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