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

Recalled January 1, 2020 · FDA recall Z-0744-2020 · Axis-Shield Diagnostics

Hazard

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

Units

740 total

Sold at

US Nationwide distribution in the states of CA, KY.

Description

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

Product

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.

Manufacturer(s)

Axis-Shield Diagnostics, Ltd.

Made in

United Kingdom

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →