CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report
St-aia Pack Afp recalled by Tosoh Bioscience
Tosoh Bioscience is recalling St-aia Pack Afp, distributed nationwide in the US. The recall was initiated on 5 Mar 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-2065-2018
- FDA event ID
- 79813
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2018
- FDA classified
- 5 Jun 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Mar 2018 | Recall initiated by company | |
| 5 Jun 2018 | Classified by FDA | +92 days |
| 13 Jun 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Questions about this recall
Why was it recalled?
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Which lots are affected?
All Lot Codes
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
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
34 other products · FDA event 79813This product is part of a recall event; the main page for the event is St-aia Pack Testosterone recalled by Tosoh Bioscience.
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
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |