The Recall Desk
ModerateFDA (Devices)·Z-0742-2020·Announced 2020-01-01

Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential under-recovery of sample results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a performance issue (under-recovery) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Axis-Shield Diagnostics, Ltd. is recalling 740 units of Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100. The affected units are identified by UDI 05055845400282 and Lot Numbers 902924530 and 902925703. The device is intended for professional use only to assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

The recall was initiated because of a potential performance issue detected during routine testing, specifically an under-recovery of sample results. This issue may affect the accuracy of test results for patients being evaluated for these conditions.

The affected products were distributed nationwide in the United States, specifically in the states of California (CA) and Kentucky (KY). Healthcare professionals and laboratories should stop using the affected reagent and contact Axis-Shield Diagnostics for further instructions or replacement.

The recalled product

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.
Manufacturer
Axis-Shield Diagnostics, Ltd.
Category
Medical Device — In Vitro Diagnostic Reagent
Hazard
Affected units
740

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI: 05055845400282
  • Lot Numbers 902924530
  • 902925703

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Axis-Shield Diagnostics, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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Same manufacturer · Axis-Shield Diagnostics, Ltd.

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