ROM Plus® Quality Control Kit ROM-QCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814247020451), received between Apr 30, 2019 and Nov 10, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Missing Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110605); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2023Missing Information; Missing Information

  IN THE CUSOTMERS WORDS: "HI, MY NAME IS (B)(6). MY PHONE NUMBER IS (B)(6). I WAS GOING TO GET INFORMATION ON ONE OF YOUR QC VIALS FOR YOUR ROM PLUS, THE POSITIVE QC. ONE OF THE GLASS SHARDS FROM THE PRODUCT ACTUALLY BROKE THROUGH THE VIAL AND ENTERED MY FINGER. AND I'M JUST TRYING TO FIGURE OUT WHAT EXACTLY WAS IN THE SOLUTION IF YOU CAN GIVE ME A CALL BACK BECAUSE I KNOW YOU SHOULD GET THE CHANCE I'D APPRECIATE IT. THANK YOU SO MUCH. BYE." 1ST AND 2ND ATTEMPT TO CALL BACK WITH NO RESPONSE ((B)(6) 2023) PHONE CONVERSATION ON (B)(6) 2023; CUSTOMER STATES THEY DID NOT USE THE INCLUDED SAFETY SLEEVE FOR THE POSITIVE CONTROL VIAL.

  Patient problems: Laceration(s)

  MAUDE report 18113385 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED GETTING "PRICKED" BY GLASS IN (B)(6) QC VIAL. IT HAPPENED A SECOND TIME WHEN USING THE (B)(6) VIAL ( SAME PRODUCT PACK-BOTH (B)(6)) LOT NUMBER TBA. THE HOSPITAL EMPLOYEE IS GOING TO FOLLOW HOSPITAL PROTOCOL AND GET TESTED. INFORMATION GIVEN ON IFU REGARDING CONTENTS OF (B)(6) VIAL. THE PRODUCT IS AVAILABLE AND WILL BE RETURNED FOR EVALUATION. THE IFU STATES THE FOLLOWING: CAUTION: THIS PRODUCT CONTAINS HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. COMPONENTS SOURCED FROM HUMAN BLOOD HAVE BEEN TESTED AND FOUND TO BE NONREACTIVE FOR HBSAG, ANTI-HIV 1/2, AND ANTI-HCV. NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN SOURCES OR INACTIVATED MICROORGANISMS WILL NOT TRANSMIT INFECTION. THEREFORE, IT IS RECOMMENDED THAT ALL HUMAN SOURCED MATERIALS BE CONSIDERED POTENTIALLY INFECTIOUS AND HANDLED WITH APPROPRIATE BIOSAFETY PRACTICES.

  Patient problems: Injury; Tissue Damage

  MAUDE report 8681135 ↗
• InjuryApr 30, 2019Sharp Edges

  CUSTOMER CALLED AND REPORTED GETTING "PRICKED" BY GLASS IN NEGATIVE QC VIAL. IT HAPPENED A SECOND TIME WHEN USING THE POSITIVE VIAL (SAME PRODUCT PACK-BOTH POSITIVE AND NEGATIVE) LOT NUMBER TBA. THE HOSPITAL EMPLOYEE IS GOING TO FOLLOW HOSPITAL PROTOCOL AND GET TESTED. INFORMATION GIVEN ON IFU REGARDING CONTENTS OF POSITIVE VIAL. THE PRODUCT IS AVAILABLE AND WILL BE RETURNED FOR EVALUATION. THE IFU STATES THE FOLLOWING: CAUTION: THIS PRODUCT CONTAINS HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. COMPONENTS SOURCED FROM HUMAN BLOOD HAVE BEEN TESTED AND FOUND TO BE NONREACTIVE FOR HBSAG, ANTI-HIV 1/2, AND ANTI-HCV. NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN SOURCES OR INACTIVATED MICROORGANISMS WILL NOT TRANSMIT INFECTION. THEREFORE, IT IS RECOMMENDED THAT ALL HUMAN SOURCED MATERIALS BE CONSIDERED POTENTIALLY INFECTIOUS AND HANDLED WITH APPROPRIATE BIOSAFETY PRACTICES.

  Patient problems: Injury; Tissue Damage

  MAUDE report 8567067 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110605. One submission often covers many models, so check the product and lot details in each record.

• Z-0541-2021 · Aug 13, 2020 · Terminated
  Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025