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21,281 catalysts · 4,728 grant · 3,655 8k filing · 3,474 device 510k · 2,896 approval · 2,000 device pma · 2,000 device recall
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21,281 catalysts · 4,728 grant · 3,655 8k filing · 3,474 device 510k · 2,896 approval · 2,000 device pma · 2,000 device recall
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6; — Reason: The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples. — Status: Ongoing
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