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Elecsys tPSA
Roche Diagnostics GmbH · Model 04641655160 · UDI-DI 07613336154366
MTF
Prescription
0
510(k) clearances
518
Adverse events
9
Recalls
13
Facilities
Description
tPSA reagent, 100 Test-Kit
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.