BEUDAMED
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    Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)

    FDA Recall
    Terminated ·Diagnostic Products Corp·Product code LYR·July 31, 2003

    H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LYR·August 27, 2008

    H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LYR·August 27, 2008

    H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

    FDA Recall
    Terminated ·BioCheck Inc·Product code LYR·December 22, 2010

    Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LYR·December 26, 2002

    Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle. The Butterfly Needle is used to fill the implant with saline.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FAF·April 30, 2010

    CT Goldseal BrightSpeed 16 PWR TIO 2 YR

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·May 24, 2018

    CT Goldseal BrightSpeed 16 PWR TIO 2 YR

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 8, 2018

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Recall
    Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Enforcement
    Class II ·Terminated·LDR Spine USA, Inc.·October 12, 2016

    Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

    FDA Recall
    Terminated ·Reckitt Benckiser LLC·Product code MOL·August 6, 2018

    COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software

    FDA Enforcement
    Class I ·Terminated·Beckman Coulter Inc.·November 28, 2018

    Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    FDA Recall
    Terminated ·Stanbio Laboratory, Inc·Product code LBR·September 18, 2006

    Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·November 10, 2009

    Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·January 29, 2009

    STAT 2 I.V. Controller, Catalog/REF No. S2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. For controlling the infusion of Intravenous fluids into the human body.

    FDA Recall
    Terminated ·ConMed Corporation·Product code LDR·April 15, 2011

    Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·November 10, 2009

    Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·January 29, 2009

    Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    FDA Recall
    Terminated ·Stanbio Laboratory, Inc·Product code LBR·September 18, 2006

    STAT 2 Pumpette I.V. Compensating Controller, Catalog/REF No. PS2, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. Product Usage: The STAT 2 Pumpette Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body. This is a disposable device with a sterile, nonpyrogenic fluid path.

    FDA Recall
    Terminated ·ConMed Corporation·Product code LDR·April 15, 2011