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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000 PSA

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 Class 2 Device Recall IMMULITE 2000 PSAsee related information
Date Initiated by FirmSeptember 30, 2024
Date PostedNovember 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0464-2025
Recall Event ID 95513
PMA NumberP930027 
Product Classification Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer - Product Code MTF
ProductIMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Code Information 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
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
Manufacturer 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).
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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 in Commerce7,332 units
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MTF
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