IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
Class I - DangerousWhat Should You Do?
- Check if you have this product: 3g Allergy specific IgE Universal kit, 3g Allergy specific IgE Universal kit (IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 (D)) Lot codes: 3g Allergy Specific IgE Lot # 461 462 463 464 465 466 467 468 469 470 471 472 473 475 476 3g Allergy Specific IgE Lot # D463 D464 D465 D466 D467 D469 D471 D472 D476 D483
- 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:
- Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
Product Codes/Lot Numbers:
3g Allergy specific IgE Universal kit, 3g Allergy specific IgE Universal kit (IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 (D)) Lot codes: 3g Allergy Specific IgE Lot # 461 462 463 464 465 466 467 468 469 470 471 472 473 475 476 3g Allergy Specific IgE Lot # D463 D464 D465 D466 D467 D469 D471 D472 D476 D483
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1674-2018
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