CF InPlex ASR Card; Catalog Number: 95-0501.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: U34xx U35xx (xx denotes sublots)
- 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:
- Hologic, Inc
- Reason for Recall:
- Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CF InPlex ASR Card; Catalog Number: 95-0501.
Product Codes/Lot Numbers:
Lot Numbers: U34xx U35xx (xx denotes sublots)
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1579-2016
Related Recalls
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Due to product exhibiting potential to generate either invalid or false negative results.