163 results
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32ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
FDA Enforcement
Class II
·Terminated·Remel Inc·December 25, 2013
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
FDA Enforcement
Class II
·Terminated·Remel Inc·July 1, 2015
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
FDA Enforcement
Class II
·Terminated·Remel Inc·July 23, 2014
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
FDA Enforcement
Class II
·Terminated·Remel Inc·July 1, 2015
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.
FDA Recall
Terminated
·Remel, Inc·Product code JWX·July 20, 2009
remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
FDA Recall
Terminated
·Remel Inc·Product code JSO·April 21, 2011
remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
FDA Recall
Terminated
·Remel Inc·Product code JSO·April 21, 2011
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.
FDA Recall
Terminated
·Remel, Inc·Product code JWX·July 20, 2009
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
FDA Recall
Terminated
·Remel Inc·Product code JTO·May 2, 2013
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.
FDA Recall
Terminated
·Remel Inc·Product code JSO·May 11, 2011
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
FDA Recall
Terminated
·Remel Inc·Product code MDB·May 19, 2015
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
FDA Recall
Terminated
·Remel Inc·Product code MDB·May 19, 2015
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
FDA Recall
Terminated
·Remel Inc·Product code MDB·June 11, 2014
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
FDA Recall
Terminated
·Remel Inc·Product code JTS·October 29, 2014
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
FDA Recall
Terminated
·Remel Inc·Product code JWY·October 20, 2022