VITROS Chemistry Products VANC Reagent recall
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics…
Why was VITROS Chemistry Products VANC Reagent recalled?
Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
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?
Lot numbers: 31-5407 (exp. date 2017-05-23), 31-5474 (exp. date 2017-07-04), 31-5506 (exp. date 2017-07-04)
- Product
- VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- US: 2740; OUS: 616
- Distribution
- Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain Singapore and Venezuela.
- Recall date
- May 3, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)