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Vitros Chemistry Products System - Crp Slides (C-Reactive Protein)
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Vitros Chemistry Products System - Crp Slides (C-Reactive Protein) | More than 10 numbers, contact manufacturer. | 192 6740 |
Issue
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
Additional information
Details
| Ortho-Clinical Diagnostics Inc. |
| 100 Indigo Creek Drive, Rochester, New York, United States, 14626 |
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