Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Siemens Material Number (SMN)/REF: Atellica CH:11099412 Lot# 453716 Expiration Date: 2020-01-28 UDI Number: Atellica: (01)00630414597508(10)453716(17)20200128
  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:
Siemens Healthcare Diagnostics, Inc.
Reason for Recall:
Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay

Product Codes/Lot Numbers:

Siemens Material Number (SMN)/REF: Atellica CH:11099412 Lot# 453716 Expiration Date: 2020-01-28 UDI Number: Atellica: (01)00630414597508(10)453716(17)20200128

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1261-2020

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