Recall Z-2742-2016— Siemens Healthcare Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2016-08-09, terminated 2020-01-06. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test). Reason: Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-09
- Terminated
- 2020-01-06
- Firm location
- East Walpole, MA, United States
Product description
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Reason for recall
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
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