Every recall we track for Tosoh Bioscience Inc — 66 in all — plus the complaints and injury reports the public filed about them.
Tosoh recalls specific testosterone test kits that may give false high or low results, causing unnecessary treatments or delayed diagnoses. Affected units include certain lot numbers on specific analyzers.
Tosoh recalls specific lots of AIA-Pack BHCG Calibrator Sets for potential HCG concentration decrease up to 20% in in vitro diagnostics.
Tosoh Bioscience recalls specific lots of BHCG pregnancy test sets due to potential 20% lower HCG concentration readings. Affected units may give inaccurate pregnancy results. Contact for replacement.
Tosoh Bioscience recalls AIA-900 Analyzers with serial numbers 10030810 and higher due to a substrate monitoring system that may not detect empty bottles, leading to incorrect test results.
Tosoh Bioscience recalls AIA-360 Automated Immunoassay Analyzers with software issue causing display freezes when touched during command execution, leading to aborted runs and unretrievable results.
Tosoh Bioscience recalls all lots of AIA-PACK B12 (Vitamin B12) for in vitro diagnostic use due to potential fluorescein interference causing inaccurate vitamin B12 test results.
Tosoh Bioscience recalls all lots of ST AIA-PACK FT3 (FT3: Free Triiodothyronine) for in vitro diagnostic use. This product is designed for quantitative measurement of Free Triiodothyronine in human serum or plasma on specific analyzers.
Tos: Tosoh recalls all lots of ST AIA-PACK Testosterone (TES) for in vitro diagnostic use only. This product is designed for quantitative testosterone measurement in human serum on specific analyzers.
Tosoh Bioscience recalls ST AIA-PACK Homocysteine (HCY) products for in vitro diagnostic use only. This recall covers all lots due to potential misuse risks.
Tosoh Bioscience recalls all lots of AIA-PACK Folate (FOL) for in vitro diagnostic use only. This product is designed for quantitative folate measurement in human serum on Tosoh AIA System analyzers.
Tosoh Bioscience recalls ST AIA-PACK ACTH diagnostic kits for accurate ACTH measurement. This in vitro diagnostic product is used for adrenal gland disorders. All lots are affected.
Tosoh recalls AIA-900 analyzers with potential timing belt misalignment causing motor damage. Five complaints reported with no serious injuries. Affected units include specific serial numbers.
Tosoh recalls AIA-900 Analyzers with potential pickup arm motor issues that may cause testing delays. No serious injuries reported in 51 complaints.
Tosoh recalls Hemoglobin A1c Control (Lot 7055) due to potential degradation affecting lab test accuracy. This may cause delays in patient results. No serious injuries reported.
Tosoh recalls AIA-900 immunoassay analyzers due to software issue causing potential test delays. Affected units may need software update to prevent inaccurate results.
Tosoh Bioscience recalls AIA-2000LA and AIA-2000ST analyzers with serial numbers 10038409, 10038509, 10048009R, 10058011, 10069507, 80018112, 80039511. Incomplete washing may cause false test results for some blood tests.
Tosoh recalls AIA-900 and AIA-2000 analyzers due to potential incubator slippage causing mechanical errors and delayed test results. No injuries reported.
Tosoh recalls AIA-2000 and AIA-900 analyzers with potential incubator slippage causing testing delays. No injuries reported. Check product codes 022100, 022100R, 022101, 022101R.
Tosoh recalls AIA-360 analyzers due to labeling changes affecting maintenance procedures. Failure to follow new requirements may cause corrosion, contamination, or system failure. Affected units have product code 019945/019945R.
Tosoh recalls G8 HPLC analyzers with software missing a 510K clearance for hemoglobin A1c testing in diabetes diagnosis. Affected units have specific serial numbers listed.
Tosoh recalls HLC-723G8-ST and HLC-723G8-LA analyzers with software version 5.23. HbAE can cause invalid diabetes test results if Flag 43 isn't enabled. Users should check software settings to avoid inaccurate readings.
Tosoh Bioscience recalls AIA Analyte Application Manual CD (part 997027) due to unapproved labeling. This CD contains manuals for 47 analyte reagent packs used with their AIA analyzers. Consumers should check if they own this CD and contact Tosoh for details.
Tosoh Bioscience recalls diabetes assay kits with part number 025260 due to potential false test results when used with Asfotase Alfa (Strensiq). Affected lots may cause inaccurate diabetes test outcomes.
Tosoh Bioscience recalls AIA-PACK TSH 3rd Generation thyroid assays due to potential false test results from Asfotase Alfa. Affected units include all lot codes of part number 020294.
Tosoh Bioscience recalls ST-AIA SHBG assay kits (part 025238) due to potential false test results. Affected units may cause inaccurate reproductive hormone measurements.
Tosoh recalls HbA1c Pretreatment Solution (PN 025718) due to potential for inaccurate blood sugar test results. Affected users should contact for guidance.
Tosoh Bioscience recalls ST-AIA Myoglobin assay kits (part #025297) due to potential false test results when used with Asfotase Alfa (Strensiq). All lot codes affected.
Tosoh Bioscience recalls ST-AIA HCG assay kits (Part 025256) due to potential false test results. All lot codes affected. Contact for remedy.
Tosoh recalls diabetes assay kits that may give inaccurate blood test results when used with Asfotase Alfa medication. Affected units include specific lot codes of ST-AIA Pack C-Peptide II.
Tosoh recalls ST-AIA Pack BMG (Part 025259) for potential false assay results in tumor marker tests. Affected units may cause inaccurate test results.
Tosoh Bioscience recalls ST-AIA PACK PAP (Part 025262) due to potential false assay results in prostate tests. Affected units may need to be replaced to ensure accurate test results.
Tosoh Bioscience recalls estradiol assay kits (part #025274) due to potential false test results. Affected units may give inaccurate hormone measurements.
Tosoh Bioscience recalls ST-AIA PACK cTnI 2nd Gen cardiac assay kits due to potential false test results from Asfotase Alfa (Strensiq) interference. All lot codes affected.
Tosoh Bioscience recalls ST-AIA PACK TT3 thyroid assay kits with part number 025282 due to potential false test results. Affected units may cause inaccurate thyroid test results.
Tosoh recalls ST-AIA PACK FT3 thyroid assay kits with part number 025286 due to potential false test results. Affected units may cause inaccurate thyroid test results.
Tosoh recalls HbA1c Calibrators due to potential for inaccurate blood sugar test results. Affected units may give falsely high or low HbA1c readings.
Tosoh Bioscience recalls ST-AIA PACK hsE2 (Part 025225) due to potential false assay results in reproductive hormone tests. All lot codes affected.
Tosoh recalls diabetes test kits with part number 025284 that may give false high or low results when used with Asfotase Alfa (Strensiq) therapy.
Tosoh Bioscience recalls ST-AIA PACK AFP assay kits due to potential false test results with Asfotase Alfa (Strensiq). Affected units include all lot codes of Part Number 025252.
Tosoh Bioscience recalls ST-AIA PACK HGH (Part 025266) due to potential false assay results in metabolic tests. Affected units may cause inaccurate test results.
Tosoh Bioscience recalls ST-AIA PACK TU thyroid assay kits due to potential false test results. Affected units may cause inaccurate thyroid test outcomes. Contact for remedy details.
Tosoh Bioscience recalls ST-AIA Cystatin C kidney marker assays due to potential false test results from Asfotase Alfa. Affected units include all lot codes of part number 025217.
Tosoh recalls HbA1c reagents with potential for inaccurate diabetes blood sugar results. Affected units may lead to incorrect diabetes management decisions.
Tosoh Bioscience recalls ST-AIA PACK FT4 thyroid assay kits with part number 025268 due to potential false test results. Affected units may cause inaccurate thyroid test results.
Tosoh Bioscience recalls ST-AIA DHEA-S assay (Part 025222) due to potential false test results. Affected units may cause inaccurate reproductive hormone measurements.
Tosoh Biosc: ST-AIA PACK LH II (Part 025296) may cause false test results in reproductive hormone assays. Affected units: all lot codes. No remedy specified in recall.
Tosoh Bioscience recalls ST-AIA PACK 27.29 (Part 025202) due to potential false assay results. Affected units may cause inaccurate tumor marker tests.
Tosoh Bioscience recalls ST-AIA CK-MB cardiac marker assays (part 025269) due to potential false test results with Asfotase Alfa. All lot codes affected.
Tosoh Bioscience recalls ST-AIA PACK Prog II assay (Part 025239) due to potential false test results. Affected units may give inaccurate reproductive hormone measurements.
Tosoh Bioscience recalls ST-AIA CEA assay kits with part number 025254 due to potential false test results from Asfotase Alfa (Strensiq) interference. All lot codes affected.
Tosoh recalls thyroid assay kits with part number 025258 that may cause false high or low test results when used with Asfotase Alfa (Strensiq).
Tosoh Bioscience recalls ST-AIA PACK PA (Part 025263) due to potential false assay results in tumor marker tests. Affected units include all lot codes.
Tosoh recalls HbA1c Control kits for inaccurate diabetes test results. Affected kits may give wrong blood sugar readings, causing health risks. Stop using immediately.
Tosoh Bioscience recalls ST-AIA PACK FSH (Part 025265) due to potential false test results with reproductive hormone assays. Affected units may cause inaccurate immunoassay results.
Tosoh recalls allergy assay kits with part number 025295 that may cause false high or low test results. Affected units include all lot codes. No remedy specified in official notice.
Tosoh recalls ST-AIA PACK HCG assay (Part 025261) due to potential false test results. All units are affected. No remedy specified in official notice.
Tosoh Bioscience recalls ST-AIA Pack Fer (Lot 025253) due to potential false anemia test results. Affected users should contact for guidance.
Tosoh Bioscience recalls ST-AIA PACK CA 19-9 assay kits due to potential false test results with certain cancer markers. Affected units may give inaccurate tumor marker measurements.
Tosoh Bioscience recalls ST-AIA Prolactin assay kits (Part 025255) due to potential false test results. Affected units may cause inaccurate reproductive hormone measurements.
Tosoh Bioscience recalls ST-AIA PACK Cort (Part 025287) due to potential false test results in metabolic assays. Affected units may cause inaccurate immunoassay results.
