CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report
Rom Plus Collection Kit Ifu recalled by Clinical Innovations
Clinical Innovations is recalling Rom Plus Collection Kit Ifu: Rom Plus Rupture of Membrane Test Rom-5025, Rom-6025, distributed in 8 states. The recall was initiated on 13 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0541-2021
- FDA event ID
- 86255
- Recalling firm
- Clinical Innovations, Murray, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2020
- FDA classified
- 7 Dec 2020
- Reported
- 16 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Aug 2020 | Recall initiated by company | |
| 7 Dec 2020 | Classified by FDA | +116 days |
| 16 Dec 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Where it was distributed
US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631
Where was it sold?
US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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