Ortho-Clinical VITROS Chemistry CREA Slides Recalled for Measurement Accuracy Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides because they failed to meet accuracy standards for low-end creatinine measurements in serum and urine.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a technical accuracy defect in the measurement range rather than a direct physical hazard.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CREA Slides (Product Code 680 2584) due to performance issues with the assay's measurement range. The product is used for in vitro diagnostic testing to quantitatively measure creatinine concentration in serum, plasma, and urine.
The recall was initiated because the slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantification (LoQ) for serum and urine samples. This failure affects the low end of the measuring range. The original low-end measuring range was 0.05 mg/dL for serum and 1.2 mg/dL for urine, but testing results indicate the revised low-end range is 0.15 mg/dL for serum and 3.2 mg/dL for urine.
The affected units were distributed worldwide, including the United States, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom. The recall covers 627,543 units across generations 7, 10, 12, 13, 15, 16, and 18. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the return or replacement of these slides.
The recalled product
- Product
- VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 627,543
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 (7)
- GEN 7
- GEN 10
- GEN 12
- GEN 13
- GEN 15
- GEN 16
- GEN 18
Distribution
Distributed nationwide across the United States.
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