Skip to content

CRP CP3826Recalls & reported problems

Randox Laboratories Limited · The CRP test system is intended for the quantitative in vitro determination of CRP concentration in serum. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 1, 2023Open, Classified

    The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

    Z-1286-2023 · Root cause: Under Investigation by firm · FDA record ↗

Other C-Reactive Protein, Antigen, Antiserum, And Control devices

All C-Reactive Protein, Antigen, Antiserum, And Control devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.