Ortho-Clinical VITROS High Sample Diluent A Reagent Pack Recall: Inaccurate TSH Test
Ortho-Clinical recalls VITROS High Sample Diluent A Reagent Pack Lot 2190 due to potential inaccurate TSH test results. Affected users should contact the manufacturer for details.
Lower-risk recall
Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.
Contact the company
What happened, in plain English
Ortho-Clinical is recalling VIT:ROS High Sample Diluent A Reagent Pack Lot 2190 because it can cause lower than expected results when used with TSH reagent packs. This may lead to incorrect thyroid function test results. Read more at govinfonow.com/recall/61509-ortho-clinical-vitros-high-sample-diluent-a-reagent-pack-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/61509-ortho-clinical-vitros-high-sample-diluent-a-reagent-pack-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0503-2022
Cite this page
“Ortho-Clinical VITROS High Sample Diluent A Reagent Pack Recall: Inaccurate TSH Test.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61509-ortho-clinical-vitros-high-sample-diluent-a-reagent-pack-recall. Based on FDA recall #Z-0503-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0503-2022%22&limit=1).
Why it’s dangerous
The recalled reagent pack can produce lower than expected results when diluted with the TSH reagent pack. This may cause inaccurate thyroid function test results, potentially leading to incorrect health decisions.
Who’s affected
Users of VITROS immunodiagnostic test kits who purchased the recalled reagent pack Lot 2190 are affected. Patients relying on thyroid function tests are most at risk.
How to tell if you have this one
Check for the lot number 2190 on the VITROS High Sample Diluent A Reagent Pack. The product code is 8430373 (10758750004898).
- Brand
Ortho-Clinical- Category
Medical device
What to do — step by step
Check Reagent Pack
Verify the lot number on the VITROS High Sample Diluent A Reagent Pack is 2190.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 36 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KY, LA, MD, ME, MI, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0503-2022 (November 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0503-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.