GKFClass II

Instrument, Hematocrit, Automated

Hematology · 21 CFR 864.5600

MDR events5All time

Recalls1All time

Registered firms55Currently listed

510(k) clearances15All time

Recent MDR events

5 adverse event reports on file

I-STAT CHEM8+ CARTRIDGESep 19, 2017
MalfunctionAbbott Point Of Care2245578-2017-00301
STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2Jun 19, 2017
MalfunctionNova Biomedical Corporation1219029-2017-00006
I-STAT CHEM 8+N CARTRIDGENov 3, 2010
MalfunctionAbbott Point Of Care Canada Ltd2245578-2010-00141
I-STAT CHEM 8+ CARTRIDGEJul 10, 2009
OtherAbbott Point Of Care Canada Ltd.2245578-2009-00018
I-STAT EG7+ CARTRIDGEMar 5, 2009
OtherAbbott Point Of Care Canada Ltd.2245578-2009-00005

Event type breakdown

Malfunction3

Other2

Most-reported manufacturers

Abbott Point Of Care Canada Ltd.2 Abbott Point Of Care1 Abbott Point Of Care Canada Ltd1 Nova Biomedical Corporation1

Recalls

1 recall events for this product code

Radiometer America Inc
TerminatedAug 2, 2006
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Bl
The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing).
Z-1316-06 · View FDA record ↗

Registered firms

55 firms currently registered for this product code

510(k) clearances

15 clearances for this product code