Date Initiated by Firm |
December 21, 2016 |
Create Date |
January 31, 2017 |
Recall Status1 |
Terminated 3 on June 07, 2018 |
Recall Number |
Z-1119-2017 |
Recall Event ID |
76124 |
PMA Number |
P930027 |
Product Classification |
Total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer - Product Code MTF
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Product |
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog)
Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
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Code Information |
Lot Numbers: 1) 0336 - Expiration date 2017-01-31 2) 0337 - Expiration date 2017-02-28 3) 0338 - Expiration date 2017-05-31 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact |
914-631-8000
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Manufacturer Reason for Recall |
Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Siemens issued an Urgent Medical Device Recall Notice letter dated December 21, 2016, to their U.S.A customers via Fed Ex and an Urgent Field Safety Notice letter dated December 2016, to customers outside the US (OUS). The notices instruct customers to discontinue use of and discard the affected kit lots listed in Table 1 of the customer communication. Customers are requested to review the UMDR and or the UFSN with their Medical Director. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days. U.S.A customers are advised to fax the Effectiveness Check questionnaire to (312) 275-7795. Field service personnel will be sent an SKB (Service Knowledge Base) describing the issue and instructing them how to deal with customer questions. Customers with questions should contact their local Siemens technical support representative. |
Quantity in Commerce |
1379 kits (190 kits in U.S.A and 1189 Kits internationally) in total |
Distribution |
Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany |
Total Product Life Cycle |
TPLC Device Report
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = MTF and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS INC.
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