Tinaquant 1Antitrypsin ver2 5991978190Recalls & reported problems
Roche Diagnostics GmbH · 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 04015630928415), received between Mar 26, 2024 and Mar 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results
THE INITIAL REPORTER RECEIVED A QUESTIONABLE AAT ALPHA-1 ANTI-TRYPSIN ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT FROM THE MODULE WAS 0.22 G/L WITH A DATA FLAG. THE PATIENT SAMPLE WAS THEN SENT TO ANOTHER SITE FOR PHENOTYPING. THE INITIAL RESULT WAS THEN QUESTIONED PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT FROM THE MODULE WAS 1.56 G/L. THIS RESULT WAS CONSISTENT WITH THE OTHER SITE'S PHENOTYPING RESULTS. THE PATIENT SAMPLE WAS AGAIN RERUN SEVERAL TIMES AND THE RESULT WAS CONSISTENTLY 1.5 G/L. THE REPEAT RESULT WAS DEEMED CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18978771 ↗
Other ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL devices
- Human alpha 1 antitrypsin Kit for use on SPAPLUS NK034.SThe Binding Site Group Limited · Alpha-1-Antitrypsin, Antigen, Antiserum, Control1 recall0 reports
- Albumin BCP 5599261190Roche Diagnostics GmbH · ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL2 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page