Class III — 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 III |
| Status | Terminated |
| Reason | The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label. |
| Product | AIA-PACK TgAb CONTROL SET |
| Quantity | 64 boxes |
| Distribution | Product was shipped to the following states: AK, FL, GA, MA, NY, NY, OH, OK & TX. |
| Initiated | 2017-02-08 |
| Classified | 2017-05-26 |
| Terminated | 2019-02-08 |
| Recall number | Z-2169-2017 |
| 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 III recall — Tosoh Bioscience, Inc. (Z-2169-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76659/
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