Albumin BCP 5599261190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630927562), received between Apr 25, 2019 and Oct 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (2 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.
Reports received per month
Most reported problems
Device problems
- Low Test Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Low Test Results; Low Test Results
THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN BCP RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE DOCTOR QUESTIONED THE LOW INITIAL RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE INITIAL RESULT WAS 1167 MG/DL. THE REPEAT RESULT WAS 4331 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23359666 ↗MalfunctionApr 25, 2019Low Test Results; Low Test Results
THIS REPORT SUMMARIZES <NOE>2</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY THE COBAS 6000 C (501) MODULE. THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS WITH LOW RESULTS FOR ALBP ALBUMIN BCP. THE PATIENTS' AGES RANGED WERE "NEWBORNS".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8551515 ↗
Other ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL devices
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- Tinaquant 1Antitrypsin ver2 5991978190Roche Diagnostics GmbH · ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL1 report
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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