Recall Z-2073-2025 ยท DJG Enzyme Immunoassay, Opiates
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
| Date | Jul 2, 2025 (initiated Jun 12, 2025) |
| Status | Open, Classified |
| Reason | Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results. |
| Root cause | Under Investigation by firm |
| Action | Quidel Ortho notified consignees on about 06/12/2025 via FedEx letter. Distributors were instructed to discontinue distribution and discard inventory of any affected lots, send the provided customer letter and Confirmation of Receipt to any affected customers, and complete and return their Confirmation of Receipt. Customers were instructed that if their laboratory is unable to generate QC results within acceptable range using lots from GEN 15 of VITROS OP Reagent, discontinue using, render unusable, and discard your inventory of VITROS OP Reagent, GEN 15. Additionally, there were requested t |
| Quantity | 2,017 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062460 | VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc., Dec 15, 2006 |