VITROS Chemistry Products DAT Performance Verifier I in recall: Labeling Error
VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
Why was VITROS Chemistry Products DAT Performance Verifier I in recalled?
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
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?
Catalog# 6802327 Lot# H5616
- Product
- VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 349
- Distribution
- Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.
- Recall date
- March 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)