BEUDAMED
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    WAMPOLE LABORATORIES

    FDA Adverse Event
    Injury ·WAMPOLE LABORATORIES DIV, CASTER-WALLACE, INC.·Product code JSC·February 2, 1996

    WAMPOLE LABORATORIES STAPH LATEX KIT

    FDA Adverse Event
    Malfunction ·NERL DIAGNOSTICS, LLC·Product code JWX·January 15, 2010

    MICROSOMAL ELISA

    FDA Adverse Event
    Malfunction ·WAMPOLE LABORATORIES·Product code JLW·September 30, 2002

    RHEUMATEX

    FDA Adverse Event
    WAMPOLE LABORATORIES·Product code DHR·August 23, 1994

    WAMPOLE ISOLATOR 10 MICROBIAL TUBE

    FDA Adverse Event
    Injury ·WAMPOLE LABORATORIES·Product code JKA·September 2, 1994

    WAMPOLE ISOLATOR

    FDA Adverse Event
    Malfunction ·WAMPOLE LABORATORIES·Product code JKA·March 9, 2005

    WAMPOLE IMPACT RUBELLA LATEX AGGLUTINATION KIT

    FDA Adverse Event
    Other ·WAMPOLE LABORATORIES·Product code LQN·March 5, 2009

    CLEAR VIEW STREP DETECTION

    FDA Adverse Event
    Malfunction ·WAMPOLE LABORATORIES·Product code JTO·January 30, 1998

    IMX TOTAL BHCG

    FDA Adverse Event
    Malfunction ·ABBOTT HEALTH PRODUCTS, INC.·Product code JHI·February 2, 2001

    CLINITEST HCG

    FDA Adverse Event
    Other ·WAMPOLE LABORATORIES, LLC.·Product code JHI·October 19, 2007

    ATHENA MULTILYTE

    FDA Adverse Event
    Malfunction ·WAMPOLE·Product code DHN·January 10, 2006

    Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA

    FDA Recall
    Terminated ·Applied Biotech Inc·Product code JHI·September 28, 2006

    Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA

    FDA Recall
    Terminated ·Applied Biotech Inc·Product code JHI·September 28, 2006

    Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code MID·August 30, 2004

    Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.

    FDA Recall
    Terminated ·NERL Diagnostics Corporation·Product code JWX·January 15, 2010

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 23, 2011

    PREVUE PREGNANCY TEST

    FDA Adverse Event
    Malfunction ·WAMPOLE LABORATORIES, DIV OF CARTER WALLACE, INC.·Product code LCX·November 13, 2001

    Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes Wampole Laboratories Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.

    FDA Recall
    Terminated ·Inverness Medical Professional Diagnostics·Product code GHH·February 15, 2007

    Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. Also manufactured for Wampole Laboratories, Princeton, NJ 08540 Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LJM·August 19, 2008

    CLEARVIEW FLU A/B

    FDA Adverse Event
    Other ·WAMPLE LABORATORIES·Product code GRP·September 13, 2005