Recall Z-0912-2018 ยท DIF Drug Mixture Control Materials
Ortho-Clinical Diagnostics
VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
| Date | Sep 22, 2017 |
| Status | Terminated |
| Reason | 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 | Under Investigation by firm |
| Action | 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 |
| Quantity | 323 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062077 | VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Inc., Nov 22, 2006 |
| K062165 | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS Ortho-Clinical Diagnostics, Jan 5, 2007 |