CLASS II Device recall · Reported 23 Sep 2020 · FDA Enforcement Report
Aia-pack Bhcg Calibration Verification Test Set-In Vitro recalled
Tosoh Bioscience is recalling Aia-pack Bhcg Calibration Verification Test Set-In Vitro Diagnostic for Bhcg-pregnancy, distributed nationwide in the US. The recall was initiated on 7 Aug 2020 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-2968-2020
- FDA event ID
- 86218
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Aug 2020
- FDA classified
- 14 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Aug 2020 | Recall initiated by company | |
| 14 Sep 2020 | Classified by FDA | +38 days |
| 23 Sep 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
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
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
Questions about this recall
Why was it recalled?
Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
Which lots are affected?
Lot Numbers: J803507, JX03508, JZ03509, A203510, A403511
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador.
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
1 other product · FDA event 86218| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Aia- Pack Hcg Calibrator Set-In Vitro Diagnostic for Bhcg recalled | Tosoh Bioscience | Potency & Assay | 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-900 Analyzer recalled by Tosoh Bioscience | Tosoh Bioscience | Potency & Assay | Nationwide |
| Device | CLASS II | AIA-360 Automated Immunoassay Analyzer, Product recalled | Tosoh Bioscience | Device Malfunction | 5 states |
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