cobas&#x00AE PCR Media Uni Swab Sample Kit 07958030190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00875197005721), received between Nov 15, 2021 and Oct 10, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryOct 10, 2024Break; Break

  A CUSTOMER ALLEGED THAT A SWAB, WHICH IS PACKAGED IN THE COBAS® PCR MEDIA UNI SWAB SAMPLE KIT, BROKE DURING SAMPLE COLLECTION. THE PATIENT WAS ALLEGEDLY COLLECTING AN OROPHARYNGEAL SWAB WHEN THE SWAB BROKE DURING SELF-COLLECTION. IT IS UNCLEAR AT WHAT POINT IN THE COLLECTION PROCESS THE SWAB BROKE AND IF ANY TREATMENT WAS ADMINISTERED. NO FURTHER HARM WAS REPORTED.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 20418158 ↗
• InjuryOct 10, 2024Break; Break

  A CUSTOMER ALLEGED THAT A SWAB, WHICH IS PACKAGED IN THE COBAS® PCR MEDIA UNI SWAB SAMPLE KIT, BROKE DURING SAMPLE COLLECTION. THE PATIENT WAS ALLEGEDLY COLLECTING AN ANORECTAL SAMPLE AND THE SWAB BROKE DURING SELF-COLLECTION. PART OF THE SWAB WAS LODGED IN THE PATIENT¿S RECTUM. THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM TO HAVE THE SWAB FRAGMENT REMOVED. IT COULD NOT BE CONFIRMED WHAT TREATMENT THE PATIENT RECEIVED OR IF THEY WERE ADMITTED. NO FURTHER HARM WAS REPORTED.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 20418143 ↗
• InjuryNov 15, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  A CUSTOMER ALLEGED TWO INCIDENTS WHEN THE WOVEN SWAB, WHICH IS PACKAGED IN THE COBAS® PCR MEDIA UNI SWAB SAMPLE KIT, BROKE OFF PREMATURELY DURING A RECTAL SELF-COLLECTION, FOR CT/NG TESTING, INSTRUCTED BY THE CLINICIAN. ONE OF THE PATIENTS WAS ABLE TO REMOVE THE BROKEN SWAB BY THEMSELVES. THE SECOND PATIENT HAD THE SWAB REMOVED IN THE EMERGENCY ROOM. IT IS UNKNOWN IF THE PATIENT HAD TO STAY IN THE HOSPITAL. IT IS ALSO UNKNOWN IF THE PATIENT WAS INJURED DURING THE INCIDENT. THE PATIENT REFUSED ANY FURTHER CONTACT WITH THE CLINIC. THE CUSTOMER INDICATED THE SWAB WAS INTACT WHEN THE CUSTOMER RECEIVED THE PRODUCT. THE COBAS® PCR MEDIA UNI SWAB KIT INSTRUCTIONS FOR USE (IFU) REFERS TO THE ASSAY SPECIFIC INSTRUCTIONS ON SWAB COLLECTIONS. ACCORDING TO THE COBAS® CT/NG IFU, THE ANORECTAL SWAB SPECIMENS SHOULD BE COLLECTED BY CLINICIANS. IN THIS CASE, THE PATIENTS WERE INSTRUCTED BY THE CLINICIANS AND PERFORMED SELF-COLLECTION, WHICH WAS NOT INDICATED IN THE PRODUCT'S IFU AND MOST LIKELY THE REASON FOR THE SWABS BREAKING.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 12814768 ↗