CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report
ST Aia-pack Testosterone (Tes) is designed recalled by Tosoh Bioscience
Tosoh Bioscience is recalling ST Aia-pack Testosterone (Tes) is designed for IN Vitro Diagnostic Use Only for the, 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-0674-2019
- 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 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.
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 81597This product is part of a recall event; the main page for the event is ST Aia-pack Acth (Acth: Adrenocorticotropic Hormone) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ST Aia-pack Acth (Acth: Adrenocorticotropic Hormone) recalled | Tosoh Bioscience | Other | Nationwide | |
| 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 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 |
Other Test Kits & Diagnostics recalls
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|---|---|---|---|---|---|
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled | Beckman Coulter | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| 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 |