JHNClass I

Turbidimetric Method, Lipoproteins

Clinical Chemistry · 21 CFR 862.1475

MDR events0All time

Recalls1All time

Registered firms16Currently listed

510(k) clearances7All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Beckman Coulter Ireland, Inc.
Open, ClassifiedMay 23, 2025
Apo B Reagent, REF: OSR6143
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
Z-1815-2025 · View FDA record ↗

Registered firms

16 firms currently registered for this product code

510(k) clearances

7 clearances for this product code