Ortho-Clinical recalls VITROS VersaTips (Catalog 6801715) due to potential 16% sample volume reduction causing inaccurate blood tests. Affected units may lead to incorrect drug dosing or false positive/negative results for infectious diseases.
The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
Take action
Contact the company
📍Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101
“Ortho-Clinical VITROS VersaTips Recall: 16% Sample Volume Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61438-ortho-clinical-vitros-versatips-recall-16-sample-volume-error-risk. Based on FDA recall #Z-0735-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0735-2022%22&limit=1).
The FDA announced on Dec. 10, 2021, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products VersaTips due to shape deformities that may cause inaccurate test results. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Ortho-Clinical
Product: VITROS Chemistry Products VersaTips
Catalog No.: 6801715
Lot code: 1039734
Units affected: 4,125
The hazard
The deformity may reduce the volume of sample or reagent dispensed by 16%. This error can lead to reduced drug dosage or false positive or negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has had 53 other recalls since July 10, 2017. Recent recalls include calibration failures affecting VITROS LAC Slides on July 29, 2025, and VITROS Ca Slides on July 9, 2025. Other recent recalls of similar products include Bioporto ProNephro AKI Reagent Kit (May 18, 2026), Vivoo Vaginal pH Test (Nov. 22, 2025), and Vivoo Protein Test (Nov. 22, 2025).
How to tell if you have this one
Check for the catalog number 6801715 on the VersaTip box. The lot number 1039734 is also associated with this recall.
Brand
Ortho-Clinical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Your VersaTips
Look for the catalog number 6801715 and lot number 1039734 on the box.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. Foreign distribution to Canada.” 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 3 months 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-0735-2022 (December 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0735-2022 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.