VITROS Chemistry Product Performance Verifier I recall
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to…
Why was VITROS Chemistry Product Performance Verifier I recalled?
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
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?
Current Control Assay Sheet SD 4.2, 4.3 Revised Control Assay Sheet SD 6.8, 7.1
- Product
- VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to…
- Recalling firm
- Ortho-Clinical Diagnostics
- Distribution
- Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Kansas, Nebraska, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Idaho, Utah, Arizona, New Mexico, California, Hawaii, Oregon , Washington, and Alaska
- Recall date
- June 24, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)