VITROS Chemistry Products CREA Slides recall
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use…
Why was VITROS Chemistry Products CREA Slides recalled?
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 and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring range is 0.15mg/dL for serum and 3.2mg/dL for urine.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GEN 7, GEN 10, GEN 12, GEN 13, GEN 15, GEN 16, GEN 18
- Product
- VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 627543
- Distribution
- Worldwide distribution. US nationwide, 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 United Kingdom.
- Recall date
- September 26, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)