Home › Beckman Coulter, Inc. › Access Total IgE Calibrator S0
Access Total IgE Calibrator S0
Beckman Coulter, Inc. · Model 35006 · UDI-DI 15099590221300
DGC
Prescription
10
510(k) clearances
40
Adverse events
3
Recalls
30
Facilities
Description
The Access Total IgE Calibrator S0 is intended for use with the Access Total IgE assay to dilute patient samples containing analyte concentrations greater than the analyte specific S6 calibrator.
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. Turbi |
| 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.