Class II — Tosoh Bioscience Inc
| Recalling firm | TOSOH BIOSCIENCE |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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%. |
| 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 |
| Quantity | 289 boxes |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Bogota, Cayman Islands, Mexico, Peru, and San Salvador. |
| Initiated | 2020-08-07 |
| Classified | 2020-09-14 |
| Terminated | 2021-06-21 |
| Recall number | Z-2967-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Tosoh Bioscience Inc (Z-2967-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86218/
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