35 results
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45ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
FDA Recall
Open, Classified
·Ion Beam Applications S.A. 3 Chemin Du Cyclotron Louvain-la-neuve Belgium·Product code LHN·April 20, 2022
Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code LBR·November 10, 2009
Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIC·November 10, 2009
Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIC·November 10, 2009
Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC902-SAM-911. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIC·November 10, 2009
ADVIA 120/2120/2120i SETpoint Calibrator
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code KRZ·June 4, 2025
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code FIP·May 16, 2024
Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code KNK·December 1, 2009
Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code KNK·December 1, 2009
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CIG·February 2, 2009
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025
ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code LBR·January 29, 2009
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code LBR·January 29, 2009
Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019