FDA Device recall Z-0671-2019
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human seru…
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human seru… by Tosoh Bioscience, citing potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0671-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-30 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
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
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
Identifiers
| code_info | all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0671-2019%22
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