Diagnostic Devices Recalls

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

One Step K in vitro diagnostic test REF: 81A4

Uric Acid in vitro diagnostic test REF: 31H0P

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

One Step P in vitro diagnostic test REF: 8194

One Step pH in vitro diagnostic test REF: 31I4P

One Step 10A in vitro diagnostic test

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Softwa...

Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Senso...

(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number...

LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Senso...

B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor

Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Compon...

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ ...

HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI ...

cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro...

Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) M...

Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT...

Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT...

Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product De...

Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is inten...

LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Rea...

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the ...

8 in 1 STI Test Kit

Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor th...

Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the preci...

DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians o...

Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay

DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;

Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Ve...

ProxiDiagnost N90; Model Number: 706110;

DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro ...

DxI 9000 Access Immunoassay Analyzer, Part Number C11137

Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its a...

FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 ...

Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past ...

STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and ST...

STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable o...

STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and S...

Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software ...