Axis-Shield Diagnostics, Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0744-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 16, 2019

Date Posted: January 1, 2020

Recall Number: Z-0744-2020

Event ID: 84043

Reason for Recall:

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

Status: Ongoing

Product Quantity: 740 total

Code Information:

UDI: 05055845400183; Lot Number 902924815

Distribution Pattern:

US Nationwide distribution in the states of CA, KY.

Voluntary or Mandated:

Voluntary: Firm initiated