Z-0541-2021Class II

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

Name: Z-0541-2021 Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Creator: Clinical Innovations, LLC
Published: 2020-08-13
License: https://open.fda.gov/license/

Clinical Innovations, LLC / initiated 2020-08-13 / Terminated

FDA source

Clinical Innovations, LLC began a recall of Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 on 2020-08-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0541-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-13
Posted: 2020-12-07
Terminated: 2024-05-24
Recalling firm: Clinical Innovations, LLC
Product: Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025
Product code: NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).
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.
FDA root cause: Process change control
Action: On August 17, 2020 through August 19, 2020, the firm sent an "URGENT SAFETY NOTICE" to customers via email informing them that the incorrect swabs (non-scored) were package with their in vitro diagnostic kits and that new instructions and training material will be provided. Customers are instructed to identify any affected products and to complete the response card that is attached to the Customer Notification Letter. Customers are also provided the option of returning the affected products to the Recalling Firm. A company representative will contact and arrange for the return of the product For any questions contact the Recalling Firm at +1-801-268-8200.
Quantity in commerce: 19450 units/kits
Distribution: US: CO, IL, IN, MO, OH, RI, UT, and VA. OUS: None
Product codes and lots: Model Number: ROM-5025 Lot Number: 192438 Model Number: ROM-6025 Lot Numbers: 192353, 192359, 192631

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0541-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0541-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-07

Product code NQM

K110605Class IRom PlusClinical Innovations, LLC / cleared 2011-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)