Tosoh Bioscience Recalls ST AIA-Pack Testosterone
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Tosoh Bioscience Inc. is recalling 310 units of ST AIA-Pack Testosterone due to potential inaccurate testosterone test results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
What Happened
The recall was initiated because Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA), which could cause falsely elevated or falsely low total testosterone results.
Which Products Are Affected
ST AIA-Pack Testosterone, for in vitro diagnostic use only for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204. UDI-DI: 14560189210032. Lot Numbers: FX12404, FY12407, FY12406, FZ12408. 310 units distributed globally with US nationwide distribution.
What You Should Do
Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures. Contact the recalling firm for further information.
Why This Matters
Erroneous test results may lead to additional testing or in limited cases, delay in diagnosis or unnecessary treatment.
Source
FDA recall number Z-2746-2026. Recalling firm: Tosoh Bioscience Inc, Grove City, OH.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,150 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.