Home › Siemens Healthcare Diagnostics Inc. › ADVIA Centaur® IgE DIL
ADVIA Centaur® IgE DIL
Siemens Healthcare Diagnostics Inc. · Model 10309952 · UDI-DI 00630414175331
1
510(k) clearances
40
Adverse events
3
Recalls
30
Facilities
Description
IgE Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| 2016-09-07 | Randox Laboratories Ltd. | According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidi |
| 2009-01-05 | Siemens Medical Solutions Diagnostics | Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper. |
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.