VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual
Pending LLM rewrite. Source: FDA_DEVICE Z-2073-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- 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.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 1527-15-2771 (exp. 17-Dec-2025)
- 1527-15-2818 (exp. 11-Apr-2026)
- 1527-15-2871 (exp. 15-May-2026).
Distribution
Distributed nationwide across the United States.
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