VITROS opiate reagent lots may give low quality control results
VITROS Chemistry Products OP Reagent Gen 15 lots are being recalled because they may generate lower than expected quality control results. 2,017 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where the stated consequence is a delay in patient results rather than a clinical hazard, which fits the Moderate band.
Plain-English summary
VITROS Chemistry Products OP Reagent Gen 15, model number 680 1997, UDI-DI 10758750001835, from Ortho-Clinical Diagnostics, Inc., is being recalled. The reagent is a dual-chambered package of ready-to-use liquid reagents used to detect opiates in urine. The action covers 2,017 units.
According to the manufacturer, lots from Generation 15 may generate lower than expected quality control results, and if the customer is unable to get passing quality control results they would be unable to run the OP-LO protocol, leading to a potential delay in patient results. The FDA classified the action as Class II.
Affected lots are 1527-15-2749 (expiring 17-Nov-2025), 1527-15-2771 (17-Dec-2025), 1527-15-2818 (11-Apr-2026) and 1527-15-2871 (15-May-2026). Distribution was worldwide, including nationwide in the United States.
Laboratories should identify affected stock using the model number, UDI-DI and lot numbers above and follow the instructions issued by Ortho-Clinical Diagnostics.
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.
- Affected units
- 2,017
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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