Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Result Bias
Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because the diluent contains endogenous CRP, which can cause falsely high test results if not subtracted.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a diagnostic inaccuracy (positively biased results) rather than a direct physical injury or contamination.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS CRP Slides, including 250-slide and 90-slide sales units (Catalog # 1926740). The recall covers 124,063 units distributed worldwide, including the United States, Puerto Rico, and 18 other countries.
The recall was initiated because CRP samples diluted using specific VITROS diluents may produce positively biased results. The diluents are manufactured using human plasma-based fluids that contain endogenous CRP. The Instructions for Use (IFUs) do not provide specific instructions for subtracting the endogenous CRP from the diluent when calculating the final sample result. Consequently, the reported result may include CRP from both the sample and the diluent, leading to inaccurate, higher-than-actual readings.
Healthcare facilities and laboratories that possess these slides should stop using them and contact Ortho-Clinical Diagnostics for further instructions on how to proceed.
The recalled product
- Product
- VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 124,063
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 (4)
- Affected Generations (GENs): 3
- 11
- 12
- 30 through 36
Distribution
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