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Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Recalled September 14, 2016 · FDA recall Z-2742-2016 · Siemens Healthcare Diagnostics
Hazard
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. · FDA Class II
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Description
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
Product
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →