Reported Apr 5, 2023 · Ongoing
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum…
Randox Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories · 515 Industrial Blvd · Kearneysville, WV · 25430-2778
Is this the product you have?
- CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP
- concentration in serum Catalogue numberCP3826
- Lot codes and dates
- GTIN05055273201765
- Batch588434
- Amount recalled
- 2 kits
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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