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Rotor 24 place for capillaries

Andreas Hettich GmbH · Model 1650 · UDI-DI 04050674030441

JPI

510(k) clearances

Adverse events

Recalls

Facilities

Description

Hematocrit rotor, 24-place

Recalls

Date	Firm	Reason
2010-02-05	Abbott 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.
2010-02-05	Abbott 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.
2010-02-05	Abbott 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.
2010-02-05	Abbott 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.
2010-02-05	Abbott 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.
2010-02-05	Abbott 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.
2010-02-05	Abbott 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.
2010-02-05	Abbott 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.
2005-06-14	Baxter Healthcare Renal Div	Operator'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.