Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # UDI Number 190028 (01)00630414595818(10)190028(17)20200420 190063 (01)00630414595818(10)190063(17)20200601 190112 (01)00630414595818(10)190112(17)20200810 190152 (01)00630414595818(10)190152(17)20201005 190205 (01)00630414595818(10)190205(17)20201221 190235 (01)00630414595818(10)190235(17)20210118 190265 (01)00630414595818(10)190265(17)20210301
- 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:
- Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
- 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 Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica¿ CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block, A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Product Codes/Lot Numbers:
Lot # UDI Number 190028 (01)00630414595818(10)190028(17)20200420 190063 (01)00630414595818(10)190063(17)20200601 190112 (01)00630414595818(10)190112(17)20200810 190152 (01)00630414595818(10)190152(17)20201005 190205 (01)00630414595818(10)190205(17)20201221 190235 (01)00630414595818(10)190235(17)20210118 190265 (01)00630414595818(10)190265(17)20210301
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1537-2020
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