Blood Establishment Computer Software And Accessories
Hematology · 21 CFR 864.9165
Recent MDR events
1,034 adverse event reports on file
- DONOR INFORMATION SYSTEM (DIS)Jul 10, 2026MalfunctionBiolife Plasma Services L.p.3016429887-2026-00006
- DONOR INFORMAITON SYSTEM (DIS)Jun 12, 2026MalfunctionBiolife Plasma Services L.p.3016429887-2026-00005
- DONOR INFORMATION SYSTEM (DIS)May 8, 2026MalfunctionBiolife Plasma Services L.p.3016429887-2026-00004
- DONOR INFORMATION SYSTEM (DIS)Mar 18, 2026MalfunctionBiolife Plasma Services L.p.3016429887-2026-00003
- BLOOD TYPING MANAGERFeb 20, 2026MalfunctionDiagnostic Grifols, S.a.3002772505-2026-00001
- INSTRUMENT MANAGER SOFTWAREFeb 11, 2026MalfunctionData Innovations Llc1225673-2026-00002
- LOOKBACK NOTIFICATION SYSTEM (LNS)Jan 2, 2026MalfunctionBiolife Plasma Services L.p.3016429-2026-00001
- EXPANSE BLOOD BANKDec 18, 2025InjuryMedical Information Technology, Inc.3009404844-2025-00005
- CLINISYS SUNQUEST, LABORATORY INFORMATION SYSTEM (LIS)Nov 12, 2025MalfunctionClinisys Inc.MW5178839
- CLINISYS SUNQUEST, LABORATORY INFORMATION SYSTEM (LIS)Nov 12, 2025MalfunctionClinisys Inc.MW5178840
Event type breakdown
Recalls
2 recall events for this product code
- SCC Soft ComputerTerminatedNov 15, 2010
SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.
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 history reports using Patient>Reports>Batch Reports>History Report option in SoftBank with SoftReports activated for patient reports, when the report is generated for more than one patient ALL of the results for the qualif
Z-0362-2011 · View FDA record ↗ - ConvaTec, IncTerminatedUnknown
Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475
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.
Z-1890-2018 · View FDA record ↗
Registered firms
127 firms currently registered for this product code
Gpi Usa, Inc.
Houston, TX, US
Wellsky Corporation. - Headquarters
Overland Park, KS, US
Biolife Plasma Services L.p.
Bannockburn, IL, US
Carter Bloodcare
Bedford, TX, US
Grifols Diagnostic Solutions Inc.
SAN DIEGO, CA, US
Cerner Corporation
Kansas City, MO, US
Scc Soft Computer
CLEARWATER, FL, US
Haemonetics Corporation
Boston, MA, US
Blood Bank Computer Systems, Inc.
Bonney Lake, WA, US
Healthcare-id, Inc.
Buffalo Grove, IL, US
Medical Information Technology, Inc.
Canton, MA, US
Data Innovations, Llc
Colchester, VT, US
Rubin & Poor, Inc.
MAPLEWOOD, NJ, US
Oracle Cerner Healthcare Solutions India Private Limited
Bangalore Karnataka, IN
Lattice, Inc.
Wheaton, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.