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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 05055845400282; Lot Numbers 902924530, 902925703
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Axis-Shield Diagnostics, Ltd.
- Reason for Recall:
- There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
UDI: 05055845400282; Lot Numbers 902924530, 902925703
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0742-2020
Related Recalls
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.