7 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code PDJ·February 23, 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code PDJ·February 9, 2022
Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.
FDA Recall
Open, Classified
·Abbott Diagnostics Technologies AS Kjelsaasveien·Product code PDJ·March 23, 2020
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code PDJ·April 17, 2023
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
FDA Recall
Open, Classified
·Abbott Laboratories·Product code PDJ·June 9, 2022
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
FDA Recall
Open, Classified
·Abbott Laboratories·Product code PDJ·June 9, 2022
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
FDA Recall
Open, Classified
·Abbott Laboratories·Product code PDJ·June 9, 2022