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    The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.

    FDA Recall
    Terminated ·Abbott Molecular·Product code MVU·March 28, 2013

    Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009

    Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009

    Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine Sample 25 Tests Model Number: DOA-1127-041-19. c. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (OX, pH, SG) Urine Sample 25 Tests Model Number: I-DUA-157-013. d. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 6-Drug Panel with Adulterants AMP, BZO, COC, mAMP/MET, OPI, THC, (OX, pH, SG) Urine Sample Tests Model Number: I-DUA-167-022. e. Alere Drugs of Abuse Test iCup Dx Pro 2 10-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, OPI300, OXY, MTD, THC (CR, OX, SG) Urine Sample 25 Tests Model Number: I-DXP-2107-01. f. Alere Drugs of Abuse Test iScreen 5-Drug Panel AMP, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: IS5M. g. Instant Technologies, Inc. Drugs of Abuse Test T-Cube 7-Drug Panel AMP50, COC20, mAMP/MET50, OPI40, OXY20, PCP10, THC40 Saliva Sample 25 Tests Model Number: TCUBE-7PCPB. h. Wondfo Drugs of Abuse Test with Adulterants Tcup 14-Drug Panel AMP1000, BAR300, BZO300, BUP10, COC300, mAMP/MET1000, MDMA500, MTD300, MOP(OPI300), OXY100, PCP25, PPX300, TCA1000, THC50 (CR, pH, SG) Urine Sample 25 Tests Model Number: TDOA-1145A3. i. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, TCA, THC, (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCUPA-12CLIA. j. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, THC (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCupA-12BUP300. k. Alere Drugs of Abuse Test E-Z Split Key Cup 6-Drug Panel AMP, BZO, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: DOA-2167-019. l. Alere Drugs of Abuse Test E-Z Split Key Cup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (CR, GL, NI, OX, pH, SG) Urine Sample 25 Tests Model Number: DUD-157-012-019. m. WONDFO USA CO., LTD. Wondfo Drug Test Dip Card Drugs of Abuse Test Tdip Single Drug Buprenorphine (BUP) Urine Sample 25 Tests Model Number: WDBU-114.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code DKZ·May 25, 2022

    DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

    FDA Recall
    Terminated ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code KPR·August 15, 2018

    IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·February 5, 2020

    IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·February 5, 2020

    BD BBL TB Stain Kit K, Catalog (REF): 212522

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTS·February 12, 2025

    BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code GAA·August 24, 2010

    VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code GAA·July 29, 2022

    Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code DOA·October 15, 2007

    Aspirated Cyto-Histological Biopsy needle

    FDA Recall
    Completed ·M.D.L. S.r.l. Via Tavani N. 1/A Delebio Italy·Product code GAA·August 5, 2021

    Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code GAA·September 1, 2009

    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code GAA·July 29, 2022

    Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US

    FDA Recall
    Open, Classified ·INNOVATIVE TOMOGRAPHY PRODUCT GMBH Universitatsstr. 136 Bochum Germany·Product code GAA·April 21, 2021

    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *NOT DISTRIBUTED WITHIN THE US

    FDA Recall
    Open, Classified ·INNOVATIVE TOMOGRAPHY PRODUCT GMBH Universitatsstr. 136 Bochum Germany·Product code GAA·April 21, 2021

    VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303

    FDA Recall
    Terminated ·Tytek Medical Inc·Product code GAA·October 5, 2020