Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
Class I - DangerousWhat Should You Do?
- Check if you have this product: (01)00630414598963(10)15308337(17)20230320 (01)00630414598963(10)27949339(17)20230529 (01)00630414598963(10)41143343(17)20230630 (01)00630414598963(10)41144343(17)20230630 (01)00630414598963(10)62969345(17)20230726 Lot Numbers: 15308337, 27949339, 41143343, 41144343, 62969345 and higher. Affects all current and future lots of the Atellica IM Folate assay until the Instructions for Use are updated.
- 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:
- Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
Product Codes/Lot Numbers:
(01)00630414598963(10)15308337(17)20230320 (01)00630414598963(10)27949339(17)20230529 (01)00630414598963(10)41143343(17)20230630 (01)00630414598963(10)41144343(17)20230630 (01)00630414598963(10)62969345(17)20230726 Lot Numbers: 15308337, 27949339, 41143343, 41144343, 62969345 and higher. Affects all current and future lots of the Atellica IM Folate assay until the Instructions for Use are updated.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1149-2023
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