99 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11
FDA Recall
Terminated
·Centers For Disease Control and Prevention·Product code OZE·April 26, 2024
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
FDA Recall
Terminated
·Conformis, Inc.·Product code LPH·October 16, 2018
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
FDA Recall
Terminated
·Conformis, Inc.·Product code LPH·September 21, 2020
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
FDA Recall
Terminated
·Product code LXC·June 28, 2021
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
FDA Recall
Terminated
·Nanosphere, Inc.·Product code OCC·October 10, 2013
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.·Product code IYN·September 6, 2023
VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011
VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023
BC Thrombin Reagent . Thrombin Time Test
FDA Recall
Terminated
·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code GJA·July 21, 2004
Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code HBA·July 16, 2010
6 cm Catheter Reservoir with 10 cm extension
FDA Recall
Terminated
·Vygon Neuro·Product code HCA·March 24, 2005
American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
FDA Recall
Open, Classified
·Integra LifeSciences Corp.·Product code HBA·September 20, 2024
American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016
American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Recall
Terminated
·American Surgical Company·Product code HBA·March 31, 2016