ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    LN 4P72-01; Lot 902920500
  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
Reason for Recall:
Devices were delivered without the required dry ice.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.

Product Codes/Lot Numbers:

LN 4P72-01; Lot 902920500

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1356-2019

Related Recalls

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Mar 18, 2025 Other Medical Devices Nationwide View Details →

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.

Mar 18, 2025 Other Medical Devices Nationwide View Details →