Axis-Shield Diagnostics, Ltd. recalls Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assis…

Recall date

September 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0744-2020

FDA classification

Class II

Brand / firm

Axis-Shield Diagnostics, Ltd.

Sold / distributed

US Nationwide distribution in the states of CA, KY.

Why it was recalled

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 homocystinuria. The device is intended for Professional use only.