Axis-Shield Diagnostics, Ltd.: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

Agency Publication Date: December 26, 2019

Affected Products

Product: 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 homocystinuria. The device is intended for Professional use only.

UDI: 05055845400282; Lot Numbers 902924530, 902925703

Lot Numbers:

Numbers

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.

UDI: 05055845400169; Lot Number 902924526

Lot Numbers:

Number

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.

UDI: 05055845400183; Lot Number 902924815

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84043

Status: Active

Manufacturer: Axis-Shield Diagnostics, Ltd.

Manufactured In: United Kingdom

Units Affected: 3 products (740 total)

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Sources: FDA iRES · Raw API Response

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Affected Products

UDI: 05055845400282; Lot Numbers 902924530, 902925703

Lot Numbers:

Numbers

UDI: 05055845400169; Lot Number 902924526

Lot Numbers:

Number

UDI: 05055845400183; Lot Number 902924815

Lot Numbers:

Number