—#161471

Product

VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic

FDA product code: DIF — Drug Mixture Control Materials
Device class: Class 1
Medical specialty: Clinical Toxicology
510(k) numbers: K062077, K062165
Affected lot / code info: Catalog# 6802328 Lot# J5617

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On September 18, 2017 a letter was sent to customers who received the BENZ reagent within the past 18 months of affected lots. The letter stated that customers may continue use of the product if QC results using VITROS DAT Performance Verifiers are within established ranges for each assay. If QC BENZ results are below established ranges, the customer should discontinue use of the product. The letter requests customers post the notification by each system that processes the VITROS BENZ Reagent. If the product was transferred outside of the facility, to notify those customers as well. Affected lots will be replaced in 6-8 weeks. Questions or concerns can be directed to 585-453-3452

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 1000 Lee Road, Rochester, New York 14606

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2017-09-22
Terminated: 2020-08-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161471. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.