Home › Roche Diagnostics GmbH › Tina-quant Complement C4 Ver.2
Tina-quant Complement C4 Ver.2
Roche Diagnostics GmbH · Model 08105545190 · UDI-DI 07613336133606
DBI
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
32
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-08-27 | Roche Diagnostics Operations, Inc. | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the re |
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.