COBAS® AmpliPrep Instrument 03051315001Recalls & reported problems
Roche Molecular Systems, Inc. · Class 1
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 04015630924615), received between Jan 11, 2016 and Jan 11, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Computer Operating System Problem” (1 report).
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
- Computer Operating System Problem1
- Device Markings/Labelling Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2016Computer Operating System Problem; Device Markings/Labelling Problem; Computer Operating System Problem; Device Markings/Labelling Problem
A US CUSTOMER FILED A COMPLAINT CASE INDICATING THAT THE HAND-HELD BARCODE SCANNER USED WITH THE COBAS AMPLIPREP INSTRUMENT MIS-IDENTIFIED A SAMPLE BARCODE ID. NO RESULTS WERE ERRONEOUSLY REPORTED AS THIS WAS IDENTIFIED BY THE CUSTOMER DURING TROUBLESHOOTING. NO HARM WAS INDICATED THROUGH THE COMPLAINT CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5358143 ↗
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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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