BEUDAMED
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    Strep-A-Chek(TM) Strips (100 pcs)

    FDA UDI
    E-Y Laboratories, Inc.·00863251000225·Strep-A-Chek™ Reagent Strips are paper strips i...

    EY-20(TM) Reagent Tube

    FDA UDI
    E-Y Laboratories, Inc.·00863251000232·The EY-20™ Reagent Tubes are a component of the...

    Gonochek®-II Reagent Tubes

    FDA UDI
    E-Y Laboratories, Inc.·00863251000218·Gonochek®-II is intended for the use in the det...

    Strep-A-Chek(TM) Kit

    FDA UDI
    E-Y Laboratories, Inc.·00863251000201·Strep-A-Chek™ Kit is intended for use in the de...

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·April 10, 2026

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·March 22, 2017

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 22, 2011

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 17, 2011

    Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage TOX Drug Screen Control 1 or Alere Triage TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen Controls are to be used with the Alere Triage TOX Drug Screen tests and Alere Triage Meters to assist the laboratory in monitoring test performance.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DIF·September 23, 2013

    AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OYE·October 2, 2017

    COULTER AC*T 5 DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·May 12, 2011

    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 16, 2025

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·November 27, 2010

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·December 1, 2011

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·December 1, 2011

    ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code JJE·July 6, 2010

    Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code GJS·December 5, 2014

    UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·November 20, 2010

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·August 29, 2024