Dundee, United Kingdom
Axis-Shield Diagnostics, Ltd. recalls
1 recall recorded since 2018, most recently on 16 September 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 September 2019
- Reason
- There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Distribution
- US Nationwide distribution in the states of CA, KY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0744-2020, Z-0743-2020, Z-0742-2020
- Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinu
- 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 homocystinur
- Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuri
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.