Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for… — Class II medical device recall Z-2967-2020
Terminated recall by Tosoh Bioscience Inc, reported 2020-09-23, distributed nationwide. Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in
| Recall number | Z-2967-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2020-08-07 |
| Classified | 2020-09-14 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-06-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | KY, MX, PE |
| Quantity | 289 boxes |
| Reason classes | specification failure |
| Lot numbers | A233534, A433535, J833531, JX33532, JZ33533 |
| Model numbers | 020361 |
Product
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay
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%.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2967-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.