Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #405566, 405567
- 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:
- Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Product Codes/Lot Numbers:
Lot #405566, 405567
Distribution:
Distributed in: AR, PA, GA, NC, KY, VA, CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1043-2017
Related Recalls
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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.
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
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.