CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report
ST Aia-pack Acth (Acth: Adrenocorticotropic Hormone) recalled
Tosoh Bioscience is recalling ST Aia-pack Acth (Acth: Adrenocorticotropic Hormone) is designed for IN Vitro Diagnostic, distributed nationwide in the US. The recall was initiated on 30 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0676-2019
- FDA event ID
- 81597
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Nov 2018
- FDA classified
- 22 Dec 2018
- Reported
- 2 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Nov 2018 | Recall initiated by company | |
| 22 Dec 2018 | Classified by FDA | +22 days |
| 2 Jan 2019 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Not stated in the enforcement report.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
The reason has not been published.
Which lots are affected?
all lots
Where was it sold?
US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 81597| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Aia-pack Folate (Fol) is designed recalled by Tosoh Bioscience | Tosoh Bioscience | Other | Nationwide | |
| CLASS II | ST Aia-pack Homocysteine (Hcy) is designed recalled by Tosoh Bioscience | Tosoh Bioscience | Other | Nationwide | |
| CLASS II | ST Aia-pack Testosterone (Tes) is designed recalled by Tosoh Bioscience | Tosoh Bioscience | Other | Nationwide | |
| CLASS II | ST Aia-pack FT3 (FT3: Free Triiodothyronine) is designed recalled | Tosoh Bioscience | Other | Nationwide | |
| CLASS II | Aia-pack B12 (Vitamin B12) is designed recalled by Tosoh Bioscience | Tosoh Bioscience | Labeling Errors | Nationwide |
More recalls from Tosoh Bioscience
All 74| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ST Aia-Pack Testosterone, IN Vitro Diagnostic Use Only recalled | Tosoh Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | Thyroglobulin Antibody (TgAB) Calibrator recalled by Tosoh Bioscience | Tosoh Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | Aia- Pack Hcg Calibrator Set-In Vitro Diagnostic for Bhcg recalled | Tosoh Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | Aia-pack Bhcg Calibration Verification Test Set-In Vitro recalled | Tosoh Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | AIA-900 Analyzer recalled by Tosoh Bioscience | Tosoh Bioscience | Potency & Assay | Nationwide |
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| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |