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STAT PROFILE

NOVA BIOMEDICAL CORPORATION · Model CCX · UDI-DI 00385480367943

JPIKHPCGACHLJGSCDSCFACEMJJSJFPJPKCGLCGZGKRJIXJKSGHS Prescription
1
510(k) clearances
64
Adverse events
9
Recalls
12
Facilities

Description

STAT PROFILE CRITICAL CARE XPRESS CONTROL FLUSH FIXTURE

Recalls

DateFirmReason
2010-02-05Abbott Point of Care Inc.Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
2010-02-05Abbott Point of Care Inc.Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
2010-02-05Abbott Point of Care Inc.Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
2010-02-05Abbott Point of Care Inc.Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
2010-02-05Abbott Point of Care Inc.Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
2010-02-05Abbott Point of Care Inc.Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
2010-02-05Abbott Point of Care Inc.Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
2010-02-05Abbott Point of Care Inc.Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
2005-06-14Baxter Healthcare Renal DivOperator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the

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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.