Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots UDI: (01)00630414595580(10)201115(17)20210201 (01)00630414595580(10)201207(17)20210601
- 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:
- Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
- 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 Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637
Product Codes/Lot Numbers:
All lots UDI: (01)00630414595580(10)201115(17)20210201 (01)00630414595580(10)201207(17)20210601
Distribution:
Distributed in: CA, DE, MD, NC, NJ, NY, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0102-2021
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