🏥 Medical Devices • 6,554 recalls
MEDLINE INDUSTRIES, LP - Northfield
The product was incorrectly shipped at room temperature rather than refrigerated.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.