Home › KAMIYA BIOMEDICAL COMPANY, LLC › K-ASSAY® Lp(a) Reagent (L)
K-ASSAY® Lp(a) Reagent (L)
KAMIYA BIOMEDICAL COMPANY, LLC · Model KAI-017 · UDI-DI 00816426020122
DFC
Prescription
1
510(k) clearances
37
Adverse events
6
Recalls
26
Facilities
Description
For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.
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.