Recall Z-0754-2016— Siemens Healthcare Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2015-12-29, terminated 2019-11-29. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.. Reason: PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU)..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-29
- Terminated
- 2019-11-29
- Firm location
- East Walpole, MA, United States
Product description
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.
Reason for recall
PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.