FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
- Recall number
- Z-0464-2025
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
- Status
- Open, Classified
- Initiated
- 2024-09-30
- Posted
- 2024-11-14
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Under Investigation by firm
- Action
- 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 uscctsfcaecfax.team@siemens-healthineers.com. Or to fax this completed form to the Customer Care Center at (312) 275-7795.
- Quantity
- 7,332 units
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P930027"]
- Product code
- MTF
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28