Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Class I - DangerousWhat Should You Do?
- Check if you have this product: Device Listing Number # D230089 Lot # 16118BD, 16159BA,16193BC,.16193BD,16208AA,16251BA 16277BD,16322BB,17005BB,17023AC
- 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 concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Product Codes/Lot Numbers:
Device Listing Number # D230089 Lot # 16118BD, 16159BA,16193BC,.16193BD,16208AA,16251BA 16277BD,16322BB,17005BB,17023AC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2611-2017
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