Clinical Innovations ROM Plus Test Kits May Give False Results
Clinical Innovations recalls ROM Plus Rupture of Membrane Test kits ROM-502: false negatives/positives due to improper swab handling. Affected kits include specific model numbers and lot numbers.
Lower-risk recall
Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.
Contact the company
What happened, in plain English
Clinical Innovations is recalling ROM Plus Rupture of Membrane Test kits ROM-5025 and ROM-6025 because improper swab handling can cause false negative or false positive results. This could lead to incorrect medical decisions if the test is used without proper technique. Read more at govinfonow.com/recall/64490-clinical-innovations-rom-plus-test-kits-may-give-false-results.
Source Summary by GovInfoNow · govinfonow.com/recall/64490-clinical-innovations-rom-plus-test-kits-may-give-false-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0541-2021
Cite this page
“Clinical Innovations ROM Plus Test Kits May Give False Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64490-clinical-innovations-rom-plus-test-kits-may-give-false-results. Based on FDA recall #Z-0541-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0541-2021%22&limit=1).
Why it’s dangerous
The kits include non-scored swabs that must be broken correctly to avoid false results. If the swab stick isn't broken properly or if scissors are used to cut the handle, the test may give incorrect results.
Who’s affected
Users of the ROM Plus Rupture of Membrane Test kits ROM-5025 and ROM-6025 are affected. Healthcare providers and individuals using these kits for medical testing are most at risk of incorrect results.
How to tell if you have this one
Check for model numbers ROM-5025 or ROM-6025 on the kit packaging. Lot numbers 192438 for ROM-5025 and 192353, 192359, 192631 for ROM-6025 are affected.
- Brand
Clinical Innovations- Category
Medical device
What to do — step by step
Check Kit Details
Look for model numbers ROM-5025 or ROM-6025 and affected lot numbers on the packaging.
Where it went and when
Where it was distributed
Distributed in 8 states.
FDA distribution: “US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Illinois, Indiana, Missouri, Ohio, Rhode Island, Utah, Virginia.
Recall timeline
FDA terminated this recall 3.8 years 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.
Questions people ask
Are there any safety risks from using this kit?
The recall is for potential incorrect results, not physical harm. There is no risk of injury from the kit itself.
Similar recalls
Latest medical device recalls
Keep exploring
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-0541-2021 (August 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0541-2021 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.