FDA Device recall Z-0743-2020
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis an…
- FDA Device
- Class II
- ongoing
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis an… by Axis Shield Diagnostics, citing there is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0743-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-09-16 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Axis Shield Diagnostics |
| Distribution | US |
Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Reason
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Identifiers
| code_info | UDI: 05055845400169; Lot Number 902924526 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0743-2020%22
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