Tina-quant IgG Gen.2 08057915190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 16, 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 07613336121320), received between Sep 14, 2026 and Sep 17, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- High Test Results1
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Low Test Results
Roche Diagnostics received a customer complaint regarding alleged discrepant Tina-quant IgG Gen.2 assay results for one cerebrospinal fluid (CSF) patient sample tested on the cobas 8000 cobas c 502 module.The initial result was 7.98 mg/L.The first repeat result was 404 mg/L with an invalidating data flag.The second repeat result at 1:10 manual dilution in decreased mode was 732 mg/L with a data flag; the final calculated result was 7320 mg/L.The third repeat result at 1:10 manual dilution was 7130 mg/L.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800777 ↗MalfunctionSep 14, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754528 ↗
Other IGG, ANTIGEN, ANTISERUM, CONTROL devices
- VIDAS® 99735Biomerieux SA · Igg, Antigen, Antiserum, Control1 recall36 reports
- BN II System 11254820Siemens Healthcare Diagnostics Products GmbH · IGG, ANTIGEN, ANTISERUM, CONTROL17 reports
- Tinaquant IgG Gen2 3507432190Roche Diagnostics GmbH · IGG, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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