Clinical Chemistry Phenobarbital, list number 1E08

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers 52803UN12, 62299UN12, and 85773UN12
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Abbott Laboratories, Inc
Reason for Recall:
Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however, internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired, it exhibit
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Clinical Chemistry Phenobarbital, list number 1E08

Product Codes/Lot Numbers:

Lot Numbers 52803UN12, 62299UN12, and 85773UN12

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1118-2013

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When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

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