Optilite IgG4 Kit Product Code: LK009.OPT.A
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #401413
- 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:
- The Binding Site Group, Ltd.
- Reason for Recall:
- A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Optilite IgG4 Kit Product Code: LK009.OPT.A
Product Codes/Lot Numbers:
Lot #401413
Distribution:
Distributed in: FL, TX, PA, CA, MA, WA, MI, CT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1089-2017
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The Binding Site Group
Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
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The Binding Site Group
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
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The Binding Site Group
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.