Randox recalls CRP immunoturbidimetric reagent due to positive bias in patient samples. Quality controls remain unaffected. Affected batches: 588434. Contact for remedy.
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
Rando: Randox Laboratories is recalling CRP immunoturbidimetric reagent because it shows a positive bias in patient samples compared to previous batches. Quality controls are unaffected, but this could lead to inaccurate test results.
The reagent shows a positive bias in patient samples, meaning test results may be higher than actual CRP levels. Quality controls do not show this bias and remain within acceptable ranges. This could lead to inaccurate test results but does not cause immediate harm.
Healthcare professionals using the CRP reagent for blood tests may be affected. Patients using the reagent for home testing are at risk of inaccurate results.
Check for the batch number 588434 on the reagent packaging. The product is sold under catalogue number CP3826 with GTIN 05055273201765.
Verify the batch number on the reagent packaging to confirm if it is 588434.
The reagent shows a positive bias in patient samples compared to previous batches, which could lead to inaccurate test results. Quality controls remain unaffected.
No, this is a potential accuracy issue that does not cause immediate harm or injury.
Check for the batch number 588434 on the reagent packaging. The product is sold under catalogue number CP3826 with GTIN 05055273201765.
We’ve drafted a message you can send Randox Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1286-2023 — Randox Laboratories Randox Laboratories Hello, I own a Randox Laboratories that is covered by recall Z-1286-2023 from Randox Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
