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Sanguin Aurora
BIOMEDICAL DATA SOLUTIONS LIMITED · Model 2.0 · UDI-DI 05060496770035
0
510(k) clearances
1,040
Adverse events (9 deaths)
2
Recalls
45
Facilities
Description
Sanguin Aurora 2.0 is indicated for use in Clinical Diagnostic Laboratories, Blood Bank and Blood Establishments where it captures test and result data from laboratory equipment. It can be applied to single tests or a panel of tests that are used to screen blood donation (whole blood or plasma) as a pre-requisite to transfusion. Typically these tests would include markers such as Hepatitis Markers and HIV and may include non-viral testing such as ABO and Rhesus confirmation of donors, patient typing and antibody screening.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-25 | ConvaTec, Inc | It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label. |
| 2010-06-22 | SCC Soft Computer | SCC Soft Computer is issuing a Correction for SoftBank II Versions: 23.1.2.x, 23.2.0.x, and 25.0.0.x software applications. Functionality issue - For clients generating patient hi |
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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.