Siemens Healthcare Diagnostics, Inc. - Siemens Atellica CH Direct Bilirubin_2 assay - Class 2 Recall
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Siemens ADVIA Chemistry Direct Bilirubin_2 assay - Class 2 Recall
ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts
Draeger Medical Systems, Inc. - Draeger Jaundice Meter JM103 - Class 1 Recall
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
Draeger Medical Systems, Inc. - Draeger Jaundice Meter JM105 - Class 1 Recall
Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
Ohmeda Medical - Giraffe Spot PT - Class 2 Recall
Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics - Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 Reagent - Class 2 Recall
Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 20, 2013 Category: Medical Equipment Source Type: alerts
