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    cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DDG·August 28, 2019

    Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of transferrin in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DDG·May 16, 2018

    Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of soluable transferrin receptor in serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code DDG·June 11, 2008

    cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DDG·August 28, 2019

    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DDG·June 9, 2022

    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DDG·June 9, 2022

    BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

    FDA Recall
    Terminated ·BD Diagnostics (GeneOhm Sciences, Inc)·Product code NQX·July 21, 2008

    BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

    FDA Recall
    Terminated ·BD Diagnostics (GeneOhm Sciences, Inc)·Product code NQX·July 21, 2008

    JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.

    FDA Recall
    Terminated ·BD Diagnostics (GeneOhm Sciences, Inc)·Product code NQX·November 11, 2008

    CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009

    CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    FDA Recall
    Terminated ·DRG International, Inc.·Product code JKD·December 21, 2021

    Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DDC·October 26, 2006

    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code PEJ·July 14, 2016

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code CDZ·May 21, 2019

    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

    FDA Recall
    Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code JLS·June 6, 2019

    Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353 PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V0821

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code LPH·September 5, 2012

    MyLab Gamma, Model 7410

    FDA Recall
    Terminated ·ESAOTE S.P.A. Sesto Fiorentino Via Degli Olmi 11 Sesto Fiorentino Italy·Product code IYN·June 11, 2018