CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report
ST Aia-pack FT3 (FT3: Free Triiodothyronine) is designed recalled
Tosoh Bioscience is recalling ST Aia-pack FT3 (FT3: Free Triiodothyronine) is designed for IN Vitro Diagnostic Use Only, 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-0673-2019
- 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 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.
Where it was distributed
US Nationwide
Questions about this recall
Is ST Aia-pack FT3 (FT3: Free Triiodothyronine) is designed for IN Vitro Diagnostic Use Only recalled?
Yes. Tosoh Bioscience recalled ST Aia-pack FT3 (FT3: Free Triiodothyronine) is designed for IN Vitro Diagnostic Use Only on 30 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0673-2019.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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