AIA-PACK B12 — Class II medical device recall Z-0671-2019
Terminated recall by Tosoh Bioscience Inc, reported 2019-01-02, distributed nationwide. Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
| Recall number | Z-0671-2019 |
|---|---|
| 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 | 2018-11-30 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2021-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 29,645 units |
| Lot numbers | B12 |
Product
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.
Reason for recall
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
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-0671-2019. 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.