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    Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LIX·January 29, 2018

    Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time).

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code LIX·January 29, 2018

    Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DJG·February 18, 2014

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIC·January 11, 2019

    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code JJW·February 6, 2014

    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DLJ·February 6, 2014

    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·August 23, 2011

    Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code LAS·October 3, 2013

    Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIF·August 5, 2011

    Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and Barbiturate Enzyme Immunoassay R2; Enzyme Conjugate Reagent (5000 tests and 500 test packaging); Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. For in-vitro diagnostic use only. Lin-Zhi International Inc. 670 Almanor Ave., Sunnyvale, CA 94085 Product Usage: Drug testing

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIS·September 8, 2011

    Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing Lin-Zhi International, Inc.' 670 Almanor Ave. Sunnyvale, CA 94085.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·October 11, 2011

    Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154355 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3 154361 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, C4 154366 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, D4 154370 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154377 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F5 159575 Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HRY·April 17, 2020

    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma

    FDA Recall
    Terminated ·Abbott Laboratories Inc.·Product code CIX·March 10, 2010

    Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of albumin concentration in serum and plasma.

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

    Albumin Gen.2, Catalog 05166861190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CIX·August 27, 2020

    Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

    FDA Recall
    Terminated ·Regenesis Biomedical Inc·Product code ILX·September 29, 2008

    Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CIX·September 11, 2019

    VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CIX·June 12, 2013

    REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HRY·June 7, 2013

    REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HRY·June 7, 2013