cobas PCR Media Dual Swab Sample Kit 07958021190Recalls & reported problems
Roche Molecular Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00875197005738), received between Jun 24, 2022 and Jun 24, 2022 — classified as 1 malfunction.
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
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER ALLEGED THAT A PATIENT SWALLOWED A SWAB FROM COBAS® PCR MEDIA DUAL SWAB SAMPLE KIT DURING SAMPLE COLLECTION. THE CLINICIAN WAS COLLECTING A THROAT SAMPLE FOR A COBAS 6800 CT/NG TEST AND THE SHAFT BROKE AND THE PATIENT SWALLOWED THE PCR MEDIA SWAB. THE CLINICIAN CONFIRMED THAT THERE WAS NO HARM, DISCOMFORT, OR INJURY TO THE PATIENT AND THE PATIENT DID NOT HAVE ANY COMPLICATIONS OR ISSUES. MEDICAL INTERVENTION WAS NOT CONFIRMED TO RETRIEVE THE SWAB FROM THE PATIENT. NO DAMAGE WAS OBSERVED ON THE SWAB ON ARRIVAL OR PRIOR TO IMMEDIATE USE AS THE CLINICIAN USES THE SWAB ON THE PATIENT. NO HARM OR INJURY INDICATED.
Patient problems: Foreign Body In Patient
MAUDE report 14806203 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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