Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360
- 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:
- Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Product Codes/Lot Numbers:
UDI: 00630414220505; Lot Numbers: 110027 110060 110065 110091 110113 110129 110137 110161 110170 110208 110224 110234 110235 110262 110265 110273 110286 110315 110330 110347 110360
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0929-2022
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