Atellica IM cPSA 10995544Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Complexed Prostate Specific Antigen (cPSA) - Atellica IM - RGT - 100T · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Siemens Atellica cPSA test is a laboratory test that measures complexed prostate-specific antigen. The 24 reports describe a laboratory reporting complexed PSA results as free PSA results to physicians. There were no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00630414598680), received between Oct 1, 2019 and Oct 1, 2019 — classified as 24 malfunctions.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- No Apparent Adverse Event24
Patient problems
- No Known Impact Or Consequence To Patient24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140664 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140657 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140656 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140647 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140644 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140635 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140626 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140622 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140620 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140611 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140606 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140600 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140597 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140591 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. REFER TO ATTACHMENT MDR 1219913-2019-00180-00203.PDF IN FOR A COMPREHENSIVE LIST OF THE MDR NUMBERS. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140586 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140579 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140578 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140568 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140565 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140556 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140552 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140545 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140537 ↗MalfunctionOct 1, 2019No Apparent Adverse Event; No Apparent Adverse Event
SIEMENS WAS MADE AWARE THAT A CUSTOMER HAS BEEN REPORTING ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) RESULTS AS FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) AND REPORTING A %FPSA TO THEIR PHYSICIANS FOR APPROXIMATELY 2 MONTHS. TWENTY FOUR MDRS ARE BEING FILED. SIEMENS HAS NOT RECEIVED ANY FURTHER INFORMATION WITH REGARDS TO FPSA TESTING ON THESE PATIENT SAMPLES. IF WE BECOME AWARE OF FPSA TESTING THAT SIGNIFICANTLY ADDS TO, OR CHANGES, THE CONTENT OF THIS MDR, WE WILL PROVIDE THIS INFORMATION IN SUPPLEMENTAL REPORTS. THE ATELLICA IM COMPLEXED PROSTATE-SPECIFIC ANTIGEN (CPSA) ASSAY IS PERFORMING AS INTENDED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE CUSTOMER REPORTING CPSA RESULTS AS FPSA. STATEMENTS ATTRIBUTED TO THIS EVENT ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9140534 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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