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Access sTfR
Beckman Coulter, Inc. · Model A32493 · UDI-DI 15099590202811
DDG
Prescription
10
510(k) clearances
2
Adverse events
6
Recalls
31
Facilities
Description
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitaive determination of soluable transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
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. |
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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.