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ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents
Siemens Healthcare Diagnostics Inc. · Model 10341113 · UDI-DI 00630414513058
2
510(k) clearances
72
Adverse events (1 deaths)
6
Recalls
39
Facilities
Description
Bilirubin Total - ADVIA Chem. - RGT - 4x672 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-05-15 | Draeger Medical Systems, Inc. | Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement. |
| 2018-05-15 | Draeger Medical Systems, Inc. | Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement |
| 2014-12-30 | Siemens Healthcare Diagnostics Inc | Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable ran |
| 2014-12-30 | Siemens Healthcare Diagnostics Inc | Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable ran |
| 2014-12-30 | Siemens Healthcare Diagnostics Inc | Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable ran |
| 2014-12-30 | Siemens Healthcare Diagnostics Inc | Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable ran |
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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.