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Vitros chemistry products system - crp slides (c-reactive protein)
Official notice
6 Nov 2024
Last checked
6 Nov 2024
An official Health Canada notice concerns Vitros chemistry products system - crp slides (c-reactive protein). QuidelOrtho™ received complaints on the affected coating of VITROS® CRP slides, related to lower-than-expected results when testing patient samples known to have elevated concentrations of CRP (>90 mg/l or >9 mg/dl). When tested neat, results were reported as being within the upper end of the measuring range (70-90 mg/l or 7-9 mg/dl) however, upon dilution, results for these samples were reported as having concentrations greater than 2x the neat result. Patient samples with a CRP concentration above 90 mg/l (9 mg/dl) (typically above 150 mg/l (15 mg/dl)) may be reported as falsely reduced when samples are tested neat, with the dilute sample results predicting greater than 2x greater than the neat result. The observed bias will vary; however, the predicted neat CRP results will generally range between 70-90 mg/l (7-9 mg/dl). Recall start date: October 25, 2024 Published 2024-11-06.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76455
Official notice
2024-11-06
The hazard
The hazard
QuidelOrtho™ received complaints on the affected coating of VITROS® CRP slides, related to lower-than-expected results when testing patient samples known to have elevated concentrations of CRP (>90 mg/l or >9 mg/dl). When tested neat, results were reported as being within the upper end of the measuring range (70-90 mg/l or 7-9 mg/dl) however, upon dilution, results for these samples were reported as having concentrations greater than 2x the neat result. Patient samples with a CRP concentration above 90 mg/l (9 mg/dl) (typically above 150 mg/l (15 mg/dl)) may be reported as falsely reduced when samples are tested neat, with the dilute sample results predicting greater than 2x greater than the neat result. The observed bias will vary; however, the predicted neat CRP results will generally range between 70-90 mg/l (7-9 mg/dl). Recall start date: October 25, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Brand: Ortho-clinical Diagnostics, Vitros Chemistry System - Crp Slides.
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Documents, notices & source
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