UnratedMedical device recall · FDA · Published November 30, 2018
Tosoh ST AIA-PACK ACTH Recall: In Vitro Diagnostic Product
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.
📍Recalling firmTosoh Bioscience Inc3600 Gantz Rd · Grove City, OH 43123-1895
✎ GovInfoNow plain-language explainer
Tosoh Biosc: Recalls all lots of ST AIA-PACK ACTH diagnostic kits used for measuring ACTH in blood tests. These kits help diagnose adrenal gland disorders like Cushing's syndrome. The recall is for safety reasons, though no specific hazard or remedy is stated in the official notice. Read more at govinfonow.com/recall/69404-tosoh-st-aia-pack-acth-recall-in-vitro-diagnostic-product.
“Tosoh ST AIA-PACK ACTH Recall: In Vitro Diagnostic Product.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69404-tosoh-st-aia-pack-acth-recall-in-vitro-diagnostic-product. Based on FDA recall #Z-0676-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0676-2019%22&limit=1).
Tosoh Bioscience Inc recalled all lots of its ST AIA-PACK ACTH diagnostic device on November 30, 2018, according to the Food and Drug Administration. The agency announced the voluntary Class II recall affecting 1,085 units distributed nationwide.
How to tell if you have it
Brand: Tosoh Bioscience
Product: ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone)
Quantity: 1,085 units
Distribution: US Nationwide
Status: Terminated
Context
GovInfoNow's records show Tosoh Bioscience Inc has 19 other recalls on record since June 11, 2017. Other recent recalls of similar products include the Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026), the Tosoh AIA-Pack BHCG Calibrator Recall (August 7, 2020), and the Tosoh AIA-900 Analyzer Recall (May 22, 2020). Other recent recalls of similar products include the GET TESTED 8 in 1 STI Test Kit Recall (November 3, 2025), the Men's Hormone Test Recall (November 3, 2025), and the QUCARE Total Cholesterol Test Recall (April 2, 2026).
How to tell if you have this one
Check for ST AIA-PACK ACTH kits used for measuring ACTH in human blood tests. All lots are included in this recall, but no specific model numbers or dates are provided.
Brand
Tosoh Bioscience
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide
Recall number
Product, codes & lots
Quantity
Z-0671-2019
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.; all lots
29645 units
Z-0672-2019
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.; all lots
19366 units
Z-0673-2019
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.; all lots
24083 units
Z-0674-2019
ST 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 deficiency of this androgen.; all lots
26745 units
Z-0675-2019
ST 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 or homocysteinuria.; all lots
992 units
Z-0676-2019
ST 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 adrenal glands such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.; all lots
1085 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the product label to confirm it is ST AIA-PACK ACTH for ACTH measurement in blood tests.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0676-2019 (November 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0676-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.