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Sources: EU EUDAMED, US FDA
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BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code OOI·November 7, 2014
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTY·February 8, 2013
Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DWF·April 18, 2019
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
FDA Recall
Terminated
·Acutus Medical Inc·Product code DYB·February 25, 2020
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
FDA Recall
Terminated
·Acutus Medical Inc·Product code DYB·February 25, 2020
Access Immunoassay Systems Quality Control Kits, Part Number: 37309 The Access Ostase QC is used for monitoring system performance of the Access Ostase assay.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJX·May 10, 2011
LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
FDA Recall
Terminated
·Lifescan Inc·Product code JJX·February 25, 2013
LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
FDA Recall
Terminated
·Lifescan Inc·Product code JJX·February 25, 2013
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code JJX·January 9, 2024
Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.
FDA Recall
Terminated
·Abbott Laboratories·Product code JJX·September 5, 2008
BD PhoenixSpec Nephelometer, Catalog #440910.
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code JQX·January 17, 2006
Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level 2, List number 136602/06F13-02; and Cardiac Marker Control Level 3, List number 136603/06F14-02. Used to verify the integrity of newly received i-STAT cTnI cartridges.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code JJX·December 17, 2010
ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JJX·January 9, 2023
Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.
FDA Recall
Terminated
·Helena Laboratories, Inc.·Product code JJX·November 7, 2016
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code JJX·August 7, 2020
VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
FDA Recall
Terminated
·Ortho-Clinical Diagnostics, Inc.·Product code JJX·October 15, 2021
Urinary Tract Infection Test
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code LJX·November 3, 2025
AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
FDA Recall
Terminated
·AmniSure International LLC·Product code JJX·October 3, 2007
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JJX·January 10, 2017
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JJX·January 10, 2017