Tina-quant Cystatin C Gen.2 6600239190Recalls & 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 04015630932399), received between Aug 14, 2025 and Aug 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
- 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.
MalfunctionAug 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results
THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT CYSTATIN C GEN.2 RESULTS FROM SIX SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE REPORTER STATED THAT THE PATIENT'S RESULTS HAD BEEN STEADY AT 1.3 MG/L IN EARLY (B)(6) 2025. AROUND LATE (B)(6) 2025, THE PATIENT WAS ADMINISTERED A RABBIT-RELATED DRUG. THEY SUSPECT THAT THE PATIENT PRODUCED RABBIT ANTIBODIES IN MID- (B)(6) 2025 AFTER THE DRUG ADMINISTRATION, WHICH INTERFERED WITH THE ASSAY. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE DISCREPANT RESULTS OF THE SIX PATIENT SAMPLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22802822 ↗
Other TEST, CYSTATIN C devices
- CYSC CYS4004Randox Laboratories Limited · Test, Cystatin C1 recall0 reports
- Atellica CH CYSC_2 11097647Siemens Healthcare Diagnostics Inc. · TEST, CYSTATIN C6 reports
- Tina-quant Cystatin C Gen.2 6600263190Roche Diagnostics GmbH · TEST, CYSTATIN C4 reports
- Tina-quant Cystatin C Gen.2 08105596190Roche Diagnostics GmbH · TEST, CYSTATIN C2 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.
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