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electronic Laboratory Information System

CARTER BLOODCARE · Model 1.0 · UDI-DI 00857222008013

MMH Prescription
0
510(k) clearances
1,040
Adverse events (9 deaths)
2
Recalls
45
Facilities

Description

iWeBB electronic Laboratory Information System (iWeBB- eLIS), also referred to as eLIS, is software for managing patient transfusion requirements, patients’ blood specimen tests, and patient laboratory results. eLIS provides the blood bank laboratory with: * Patient management * Request order management * Patient testing management * Product order and fulfillment management including an interface to the blood center’s product inventory * Computer crossmatch and manual crossmatch data management * Interfaces to laboratory instruments. Trained laboratory personnel use eLIS to record patient information, manage specimens, enter single and batch test orders, and maintain test results. In concert with inventory control modules in other blood establishment computer software, eLIS can be used to complete cross match of a patient’s requirements with products in inventory, manage blood orders and maintain product data related to patient transfusions.

Recalls

DateFirmReason
2018-04-25ConvaTec, IncIt 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.
2010-06-22SCC Soft ComputerSCC 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.