Axis-Shield Diagnostics, Ltd. recalls Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT,
Recalled 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.
Hazard / Issue
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Issued by
FDA
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