FDA-Device2020-01-01Class II
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.
Axis-Shield Diagnostics, Ltd.
Hazard
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Sold states
US Nationwide distribution in the states of CA, KY.
Affected count
740 total
Manufactured in
17 Luna Place, Dundee, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2020Don't want to check this manually?
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