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Tosoh Bioscience Inc

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of recall (Z-2746-2026)Tosoh Bioscience Inc2026-07-16
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020 recall (Z-2967-2020)Tosoh Bioscience Inc2020-09-14
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for B recall (Z-2968-2020)Tosoh Bioscience Inc2020-09-14
AIA-360 Automated Immunoassay Analyzer, Product Code 019945 recall (Z-1420-2020)Tosoh Bioscience Inc2020-02-11
AIA-PACK TPOAb CONTROL SET recall (Z-2168-2017)Tosoh Bioscience, Inc.2017-05-15
AIA-PACK TgAb CONTROL SET recall (Z-2169-2017)Tosoh Bioscience, Inc.2017-05-15
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/packag recall (Z-2282-2016)Tosoh Bioscience, Inc.2016-07-25
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin A recall (Z-2066-2015)Tosoh Bioscience, Inc.2015-07-14
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemogl recall (Z-1075-2013)Tosoh Bioscience Inc2013-04-10
Hemoglobin F & A2 Calibrator, 0.2 mL, 4 brown glass vials/box. Mfr. By: Tosoh Bioscience, recall (Z-3030-2011)Tosoh Bioscience Inc2011-08-17
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibratio recall (Z-0007-2008)Tosoh Bioscience Inc2007-10-03
TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators recall (Z-0082-2007)Tosoh Bioscience Inc2006-10-28
TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantit recall (Z-0558-06)Tosoh Bioscience Inc2006-02-23
Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distri recall (Z-0131-06)Tosoh Bioscience, Inc.2005-11-15
TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers recall (Z-0218-05)Tosoh Bioscience, Inc.2004-11-30
Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack recall (Z-0197-05)Tosoh Bioscience, Inc.2004-11-16

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Every clearance here is in the API, with alerts when new ones post.