Access Hybritech PSA
Beckman Coulter, Inc. · Model C22845 · UDI-DI 15099590701673
Description
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-30 | Siemens Healthcare Diagnostics, Inc. | 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). |
| 2016-12-21 | Siemens Healthcare Diagnostics, Inc. | Negative bias results with the IMMULITE /IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siem |
| 2016-12-21 | Siemens Healthcare Diagnostics, Inc. | 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 |
| 2016-11-18 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instruct |
| 2016-11-18 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions f |
| 2015-12-29 | Siemens Healthcare Diagnostics, Inc | PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). |
| 2013-10-14 | BioMerieux SA | Product is not approved or authorized for distribution in the US. |
| 2012-04-02 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed a report of leaking Flex(R) reagent cartridge lot 11300BB from Dimension Vista(R) TPSA; when a leaking Flex(R) is used, patient test results may be falsely de |
| 2008-03-24 | Siemens Healthcare Diagnostics Inc. | False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this |
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