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Recall Observatory FDA recall evidence

Device product

Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025

Z-0541-2021

August 13, 2020

Class II

Product summary

Firm
Clinical Innovations, LLC
Event
Event 86255
Status
Terminated
Classification
Class II
Quantity
19450 units/kits
Official record key
device-enforcement:Z-0541-2021

Official wording

Reason: 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.

Code information: Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631

Distribution pattern: US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.