CYSC CYS4004Recalls & reported problems
Randox Laboratories Limited · The device is intended for the quantitative in vitro determination of Cystatin C in serum or plasma. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 7, 2024Open, Classified
Cystatin C Reagent marketed without a 510 (k)
Z-2425-2024 · Root cause: No Marketing Application · FDA record ↗
Other Test, Cystatin C devices
- 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
- Tina-quant Cystatin C Gen.2 6600239190Roche Diagnostics GmbH · TEST, CYSTATIN C1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.