Lower riskMedical device recall · FDA · Published June 12, 2025
Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results
Ortho-Clinical recalls VITROS OP Reagent Gen 15 (model 680 1997) due to potential lower quality control results, risking delayed patient testing. Affected units have specific lot numbers and expiration dates.
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.
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Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
✎ GovInfoNow plain-language explainer
Ortho-Clinical is recalling VITROS OP Reagent Gen 15 (model 680 1997) because it may produce lower quality control results, which could delay patient testing if the system fails to run the OP-LO protocol. This affects labs using the reagent for urine opiate testing. Read more at govinfonow.com/recall/52048-ortho-clinical-vitros-op-reagent-gen-15-may-cause-inaccurate.
“Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52048-ortho-clinical-vitros-op-reagent-gen-15-may-cause-inaccurate. Based on FDA recall #Z-2073-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2073-2025%22&limit=1).
The FDA announced on June 12, 2025, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products OP Reagent Gen 15 due to potential lower than expected quality control results. The agency issued recall number Z-2073-2025 for the device.
How to tell if you have it
Brand: Ortho-Clinical
Product: VITROS Chemistry Products OP Reagent Gen 15
Model Number: 680 1997
Lot Numbers: 1527-15-2749, 1527-15-2771, 1527-15-2818, 1527-15-2871
The hazard
According to the FDA, lots from Generation 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control results. If customers cannot obtain passing quality control results, they would be unable to run the OP-LO protocol, leading to a potential delay in patient results.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), Vivoo pH Test Recall (Nov. 22, 2025), and Vivoo Vaginal pH Test Recall (Nov. 22, 2025).
How to tell if you have this one
Check for model number 680 1997 on the reagent package. Look for lot numbers 1527-15-2749 (exp. Nov 2025), 1527-15-2771 (exp. Dec 2025), 1527-15-2818 (exp. Apr 2026), or 1527-15-2871 (exp. May 2026).
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Lot Numbers
Verify the lot number on the reagent package to see if it matches the affected numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2073-2025 (June 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2073-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.