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Blood Typing Manager

DIAGNOSTIC GRIFOLS SA · Model 210404 · UDI-DI 08436583731215

MMH Prescription

510(k) clearances

1,040

Adverse events (9 deaths)

Recalls

Facilities

Description

Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager includes the following features: • Bidirectional connectivity with one or more LIS. • Provides the ability to centralize the management of Quality Control. • Allows user to view and validate results remotely prior to export to LIS. • Allows to create and print reports. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.

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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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.