Ortho-Clinical VITROS VersaTips Recall: Deformed Tips Cause Sample Errors
Ortho-Clinical recalls VITROS VersaTips from specific lots due to deformities that may cause up to 16% sample measurement errors in lab tests. Affected lots include VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, and XT7600 models.
Lower-risk recall
A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.
Contact the company
What happened, in plain English
Ortho-Clinical is recalling VITROS VersaTips used in lab testing because some versions have deformities that can cause sample measurement errors up to 16%. This affects lab equipment accuracy and could lead to incorrect test results if not fixed. Read more at govinfonow.com/recall/63423-ortho-clinical-vitros-versatips-recall-deformed-tips-cause-sample-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/63423-ortho-clinical-vitros-versatips-recall-deformed-tips-cause-sample-errors · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1136-2021
Cite this page
“Ortho-Clinical VITROS VersaTips Recall: Deformed Tips Cause Sample Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63423-ortho-clinical-vitros-versatips-recall-deformed-tips-cause-sample-errors. Based on FDA recall #Z-1136-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1136-2021%22&limit=1).
Why it’s dangerous
Deformed VersaTips can cause sample measurement errors of up to 16% in immunometric and competitive assays. This means lab results might be inaccurate, potentially leading to incorrect diagnoses or treatment decisions.
Who’s affected
Lab users with VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, or XT7600 models who use the VersaTips for sample dispensing. The risk is highest for labs that rely on precise measurements for critical tests.
How to tell if you have this one
Check if your VITROS 250, 350, ECi, 5,1 FS, 3600, 4600, 5600, or XT7600 models have lot number 413420. The VersaTips are used to dispense samples for MicroSlide and MicroWell assays.
- Brand
Ortho-Clinical- Category
Medical device
What to do — step by step
Check Lot Number
Look for lot number 413420 on the VersaTips packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 38 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the…” 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, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-1136-2021 (January 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1136-2021 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.