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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- 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
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 →Related recalls
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