FDA Device recall Z-0675-2019
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum…
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum… by Tosoh Bioscience.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0675-2019 |
| 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
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
Reason
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.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0675-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.