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.
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.
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.
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.
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.
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.
Look for model numbers ROM-5025 or ROM-6025 and affected lot numbers on the packaging.
The recall is due to a risk of false negative or false positive results if the swab stick isn't broken correctly or if scissors are used to cut the handle.
Check the model and lot numbers on the packaging to see if it's affected. If it is, you may need to use the kit correctly or contact Clinical Innovations for more information.
The recall is for potential incorrect results, not physical harm. There is no risk of injury from the kit itself.
We’ve drafted a message you can send Clinical Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-0541-2021 — Clinical Innovations Clinical Innovations Hello, I own a Clinical Innovations that is covered by recall Z-0541-2021 from Clinical Innovations. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
