Home › Siemens Healthcare Diagnostics Inc. › Dimension® Flex® reagent cartridge TRNF
Dimension® Flex® reagent cartridge TRNF
Siemens Healthcare Diagnostics Inc. · Model 10444985 · UDI-DI 00842768005244
1
510(k) clearances
2
Adverse events
6
Recalls
31
Facilities
Description
Transferrin Flex® reagent cartridge, 120 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-09 | Randox Laboratories Ltd. | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical cal |
| 2022-06-09 | Randox Laboratories Ltd. | A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical cal |
| 2019-08-28 | Roche Diagnostics Operations, Inc. | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| 2019-08-28 | Roche Diagnostics Operations, Inc. | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| 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. |
| 2008-06-11 | Roche Diagnostics Corp. | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
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.