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This page shows you the most recent publications within this specialty of the MedWorm directory.

Sunquest Information Systems, Inc. - Sunquest Laboratory - Class 2 Recall
Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assur...
Source: Medical Device Recalls - September 7, 2012 Category: Medical Equipment Source Type: alerts

Becton Dickinson & Co. - BD GeneOhm VanR Assay - Class 2 Recall
BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BD Gen...
Source: Medical Device Recalls - September 6, 2012 Category: Medical Equipment Source Type: alerts

Cepheid - Cepheid Xpert MRSA/SA Blood Culture - Class 1 Recall
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - July 1, 2010 Category: Medical Equipment Source Type: alerts

Sunquest Information Systems, Inc. - Sunquest Laboratory System. - Class 2 Recall
Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, s...
Source: Medical Device Recalls since July 07, 2006 - November 12, 2008 Category: Medical Equipment Source Type: alerts

BD Diagnostics (GeneOhm Sciences, Inc) - BD GeneOhm MRSA - Class 2 Recall
BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guid...
Source: Medical Device Recalls since July 07, 2006 - October 31, 2008 Category: Medical Equipment Source Type: alerts

BD Diagnostics (GeneOhm Sciences, Inc) - BD GeneOhm MRSA - Class 2 Recall
BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide ...
Source: Medical Device Recalls since July 07, 2006 - October 31, 2008 Category: Medical Equipment Source Type: alerts