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Pointe Scientific, Inc. Lipoprotein (a)
HORIBA INSTRUMENTS INCORPORATED · Model L7597-CAL · UDI-DI 00811727011831
DFC
Prescription
1
510(k) clearances
37
Adverse events
6
Recalls
26
Facilities
Description
Pointe Scientific, Inc. Lipoprotein (a) Calibrator Set for in vitro use only. This five level calibrator set is intended for use in the quantitative determination of Lp(a) in human serum by immunoturbidimetric analysis.
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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Get your free API keyRead the docsData 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.