FDA Device Intelligence
Home › Siemens Healthcare Diagnostics Inc. › Atellica CH DBil_2

Atellica CH DBil_2

Siemens Healthcare Diagnostics Inc. · Model 11097532 · UDI-DI 00630414595801

JFM
1
510(k) clearances
31
Adverse events
9
Recalls
6
Facilities

Description

Direct Bilirubin (Dbil_2) Atellica CH - RGT 1792T

Recalls

DateFirmReason
2023-10-11Randox Laboratories Ltd.Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
2023-07-10Siemens Healthcare Diagnostics, Inc.Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell
2023-07-10Siemens Healthcare Diagnostics, Inc.Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell
2023-07-10Siemens Healthcare Diagnostics, Inc.Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell
2023-07-10Siemens Healthcare Diagnostics, Inc.Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell
2020-02-13Siemens Healthcare Diagnostics, Inc.Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-02-13Siemens Healthcare Diagnostics, Inc.Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-02-13Siemens Healthcare Diagnostics, Inc.Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-02-13Siemens Healthcare Diagnostics, Inc.Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

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 docs
Data 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.