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Turbidimetric Method, Lipoproteins
FDA product code JHN · Class 1 · Clinical Chemistry
13
Registered devices
0
Adverse events
1
Recalls
7
510(k) clearances
Devices with this code
APO B — RANDOX LABORATORIES LIMITEDHuman Apolipoprotein B (Apo B) kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDAPO A-I — RANDOX LABORATORIES LIMITEDAPO A-I — RANDOX LABORATORIES LIMITEDAPO B — RANDOX LABORATORIES LIMITEDAU — Beckman Coulter, Inc.APO A-I — RANDOX LABORATORIES LIMITEDAPO B — RANDOX LABORATORIES LIMITEDHuman Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDAPO B — RANDOX LABORATORIES LIMITEDAU — Beckman Coulter, Inc.APO A-I — RANDOX LABORATORIES LIMITEDAU — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-23 | Beckman Coulter Ireland, Inc. | 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 |
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