Becton Dickinson & Co. - BD GeneOhm MRSA ACP Assay - Class 2 Recall
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BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. . (Source: Medical Device Recalls)
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Oculus Innovative Sciences Inc - Microcyn Dermatology Spray - Class 2 Recall
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Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. 99.999% Reduction In-solution in 30 seconds. MRSA - Staphylococcus aureus VFR - Enterococcus faecalis Acinetobacter baumannii Pseudomonas aeruginosa. Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product. Safe to use around eyes, nose and mouth. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management via debridement of wounds (Source: Medical Device Recalls)
Oculus Innovative Sciences Inc - Puracyn OTC Wound & Skin Care Solution - Class 2 Recall
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Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. Does not contain Antibiotics, Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around eyes, nose, m mouth and open wounds - Accelerated healing of minor wounds by keeping the wound clean -Non-toxic and non-irritating. Manufactured by Oculus Innovative Sciences for Innovaycen, Inc. 3546 N. Riverside Ave. Rialto, CA 92377 Made in USA. Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. (Source: Medical Device Recalls)
Cepheid - Cepheid Xpert MRSA/S Blood Culture - Class 3 Recall
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Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001; (Source: Medical Device Recalls)
Remel Inc - Remel Spectra MRSA - Class 2 Recall
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Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS. The product is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. It is also intended for use in the qualitative detection of MRSA from positive blood cultures demonstrating gram-positive cocci on Gram stain. (Source: Medical Device Recalls)
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Becton Dickinson & Co. - BBL OXACILLIN SCREEN AGAR - Class 2 Recall
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BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates. Oxacillin Screen Agar (originally named MRSA Screen Agar) was developed for the detection of methicillin-resistant Staphylococcus aureus (MRSA). These strains are resistant to penicillinase-resistant penicillins (PRPs), such as methicillin, oxacillin and nafcillin. Since the method to detect MRSA uses the same inoculum as the Bauer-Kirby antimicrobial disc susceptibility test procedure, the oxacillin screen test may be conveniently performed on isolates at the same time as routine susceptibility testing. (Source: Medical Device Recalls)
FDA Clears Fast MRSA Test
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WASHINGTON (MedPage Today) -- The FDA has cleared the first test that quickly distinguishes between methicillin resistant or methicillin susceptible Staphylococcus aureus bacteria. (Source: MedPage Today Product Alert)
Cepheid - Cepheid Xpert MRSA/SA Blood Culture - Class 1 Recall
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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)
Remel, Inc - Oxoid dry Spot Staphytect Plus - Class 2 Recall
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Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties. (Source: Medical Device Recalls since July 07, 2006)
Remel, Inc - Staphytect Plus - Class 2 Recall
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Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties. (Source: Medical Device Recalls since July 07, 2006)
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No New Year's Joy from FDA
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The usual year-end rush of FDA approvals has been slowed by regulatory speed bumps as encountered by Pfizer's updated pneumococcal conjugate vaccine Prevnar 13, and Basilea's anti-MRSA agent ceftobiprole. (Source: MedPage Today Product Alert)
BD Diagnostics (GeneOhm Sciences, Inc) - BD GeneOhm MRSA Assay - Class 2 Recall
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BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen. (Source: Medical Device Recalls since July 07, 2006)
Remel, Inc - Dryspot (R) Staphytect Plus - Class 3 Recall
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Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties. (Source: Medical Device Recalls since July 07, 2006)
BD Diagnostics (GeneOhm Sciences, Inc) - BD GeneOhm MRSA - Class 2 Recall
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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 or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing. (...
September 21, 2007: Immunizations Are Discontinued in Two HIV Vaccine Trials
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The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced on September 21, 2007, that based on a review of interim data, all sites in the STEP study ceased administering the investigational vaccine. (Source: Clinical Alerts and Advisories)
January 18, 2006: International HIV/AIDS Trial Finds Continuous Antiretroviral Therapy Superior to Episodic Therapy
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The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced on January 18, 2006, that enrollment into a large international HIV/AIDS trial comparing continuous antiretroviral therapy with episodic drug treatment guided by levels of CD4+ cells has been stopped. Enrollment was stopped because those patients receiving episodic therapy had twice the risk of disease progression (the development of clinical AIDS or death), the major outcome of the study. (Source: Clinical Alerts and Advisories)