N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 802907632, Exp. 2017-02-13
- 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:
- Siemens Healthcare Diagnostics, Inc.
- Reason for Recall:
- The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Product Codes/Lot Numbers:
Lot 802907632, Exp. 2017-02-13
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1227-2017
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