Home / Recalls / Axis-Shield Diagnostics, Ltd. / Z-0742-2020

Z-0742-2020 Class II Ongoing

Recalled by Axis-Shield Diagnostics, Ltd. — Dundee

Recall Details

Product Type
Devices
Report Date
January 1, 2020
Initiation Date
September 16, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
740 total

Product Description

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.

Reason for Recall

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

Distribution Pattern

US Nationwide distribution in the states of CA, KY.

Code Information

UDI: 05055845400282; Lot Numbers 902924530, 902925703

Other recalls by Axis-Shield Diagnostics, Ltd.

  • Z-0743-2020 Class II — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 (September 16, 2019)
  • Z-0744-2020 Class II — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 (September 16, 2019)
  • Z-1946-2015 Class II — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 100 (March 20, 2015)