BEUDAMED
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    Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate amoinotransferase in human serum

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CIT·August 25, 2008

    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·May 11, 2016

    Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code LON·March 15, 2019

    VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code LON·October 22, 2018

    AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in human serum

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CIT·August 25, 2008

    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

    Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

    FDA Recall
    Terminated ·Remel Inc·Product code JWY·October 20, 2022

    Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA

    FDA Recall
    Terminated ·St. Jude Medical Daig Division·Product code DYB·September 20, 2005

    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 24, 2016

    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 24, 2016

    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 24, 2016

    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 24, 2016

    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·February 24, 2016