FDADecember 22, 2016device
Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Power outages causes reporting software to shutdown.
What to do
FDA enforcement status: Terminated
Brands named
tosoh smdtosoh
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay2020-08-07
- FDATosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay2020-08-07
- FDAAIA-900 Analyzer, Part no. 022930, UDI 045601892839922020-05-22
- FDAAIA-360 Automated Immunoassay Analyzer, Product Code 0199452020-01-10
- FDAAIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 0207062019-11-15
- FDAST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficien...2018-11-30
- FDAST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adr...2018-11-30
- FDAST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia ...2018-11-30
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