BEUDAMED
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    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    FDA Enforcement
    Class II ·Terminated·Life Technologies Corporation·April 25, 2018

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    FDA Enforcement
    Class II ·Terminated·Stanbio Laboratory, LP·September 5, 2018

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code GHQ·February 7, 2018

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    FDA Recall
    Terminated ·Product code GKR·February 8, 2018

    G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JPD·August 18, 2010

    VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007

    Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007

    Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007

    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBF·October 16, 2020

    M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall

    FDA Recall
    Terminated ·New Wave Endo-Surgical, Corp.·Product code HCF·July 8, 2020

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·March 24, 2016

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·November 16, 2016

    Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code GKF·May 24, 2005

    Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws).

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code HBF·July 8, 2011

    Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004

    Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004

    Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004