CRP Immunoturbidimetric Reagent Recalled for Positive Bias in Patient Samples
Randox Laboratories is recalling CRP Immunoturbidimetric reagent Batch 588434 because the antibody component shows a positive bias on patient samples, producing elevated test results compared to previous batches. Quality control samples remain within acceptable range.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic reagent with identified measurement accuracy issue (positive bias affecting patient sample testing). No reported illnesses or injuries, but false test results could lead to misdiagnosis. Qualifies as risk-of-harm product where injury has not yet been reported.
Plain-English summary
Randox Laboratories is recalling CRP Immunoturbidimetric reagent (Catalog CP3826, Batch 588434) distributed to Pennsylvania, Ohio, and West Virginia. The reagent is used to measure C-reactive protein (CRP) levels in blood serum for diagnostic purposes.
During quality monitoring, the manufacturer identified that the antibody component (R2 reagent) in this batch shows a positive bias when tested against patient samples, resulting in test results that read higher than expected compared to previous batches of the same product. Quality control samples tested with the same batch do not exhibit this bias and remain within acceptable ranges.
This positive bias in patient sample testing could lead to falsely elevated CRP results, potentially affecting clinical interpretation of inflammatory markers and patient care decisions. Laboratories using this reagent should consider retesting affected patient samples if they were analyzed with Batch 588434.
Customers who have received this product should contact Randox Laboratories for information about product replacement or alternative testing approaches.
The recalled product
- Product
- CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
- Manufacturer
- Randox Laboratories
- Hazard
- measurement-bias
- false-positive-results
- diagnostic-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 05055273201765 Batch: 588434
Distribution
Distributed in 3 states:
- OH
- PA
- WV
Related recalls
Same category
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01