Lp(a) Ultra

SENTINEL CH. SPA · Model 11504D · UDI-DI 08058056680211

DFC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.

Recalls

Date	Firm	Reason
2024-12-20	Randox Laboratories, Limited	Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
2024-12-20	Randox Laboratories, Limited	Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
2018-05-16	Abbott Laboratories, Inc	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
2012-01-30	Wako Chemicals USA, Inc.	In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.
2005-01-10	Diasorin Inc.	QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was d
2004-03-29	Kamiya Biomedical Company	Assay result not consistent with the assigned control value

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.