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 performance issues detected during routine testing.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific hospitalizations or serious injuries are reported in the source text, but the defect poses a risk of adverse health consequences through diagnostic error.
Plain-English summary
Axis-Shield Diagnostics, Ltd. is recalling 740 units of the Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Part Number FHRWR1000. The recall is due to a potential performance issue identified as an under-recovery of sample results during routine testing. The device is intended for professional use only and assists in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The affected product is identified by UDI 05055845400183 and Lot Number 902924815. The recall covers units distributed nationwide in the states of California and Kentucky. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare professionals and laboratories should stop using the affected reagent and contact Axis-Shield Diagnostics, Ltd. for further instructions on returning or disposing of the product. Consumers are not directly affected as the device is for professional use only.
The recalled product
- 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.
- Manufacturer
- Axis-Shield Diagnostics, Ltd.
- 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 (2)
- UDI: 05055845400183
- Lot Number 902924815
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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