CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
- 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:
- Biocare Medical, LLC
- Reason for Recall:
- A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
Product Codes/Lot Numbers:
Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1535-2015
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