Siemens IMMULITE PSA Assay Recalled for High-Dose Hook Effect Failure
Siemens Healthcare Diagnostics is recalling IMMULITE PSA assays because they do not meet the high-dose hook effect expectations stated in the Instructions for Use.
- Product
- IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics…
- Category
- Medical Device
- Distribution
- Distributed nationwide