107 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity 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 JHS·June 12, 2013
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JHS·April 1, 2020
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity 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 JHS·June 12, 2013
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JHS·April 1, 2020
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018