Randox Laboratories Ltd. - Total Bilirubin - Class 2 Recall
RANDOX Total Bilirubin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2023 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Atellica CH Total Bilirubin_2 - Class 2 Recall
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2023 Category: Medical Devices Source Type: alerts
Roche Diagnostics Operations, Inc. - Cobas u 601 urinalysis test system - Class 2 Recall
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 19, 2021 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics - VITROS XT Chemistry Products TBILALKP Slides - Class 2 Recall
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2020 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics - EKTACHEM CLINICAL CHEM. SLIDES - Class 2 Recall
VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide) (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2020 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics - VITROS Chemistry Products CRBM Slides - Class 2 Recall
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Siemens Dimension Total Bilirubin Flex reagent cartridge - Class 2 Recall
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Siemens Dimension Vista Total Bilirubin Flex reagent cartridge - Class 2 Recall
Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista¿ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Siemens ADVIA Chemistry Total Bilirubin_2 assay - Class 2 Recall
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry systems. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block. A total bilirubin measurement in newborn infants is intended to aid in indic...
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts
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 Atellica CH Total Bilirubin_2 assay - Class 2 Recall
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measure...
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
Beckman Coulter Inc - Class 2 Recall
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge) (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2020 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc - Class 2 Recall
Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge) (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2020 Category: Medical Devices Source Type: alerts
Roche Diagnostics Operations, Inc. - Bilirubin Total Gen.3 - Class 3 Recall
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 17, 2019 Category: Medical Devices Source Type: alerts
