Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number/UDI/Exp. Date: 1) 19247AB UDI: 0084276803903419247AB20090310642444840 Exp.2020-09-03, (2) 19282BB UDI: 0084276803903419282BB20100810642444840 Exp. 2020-10-08, (3) 19330BD UDI:0084276803903419330BD20112510642444840 Exp. 2020-11-25. Expanded Recall: 3/10/21 20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA, 20078AB.
- 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:
- Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
Product Codes/Lot Numbers:
Lot Number/UDI/Exp. Date: 1) 19247AB UDI: 0084276803903419247AB20090310642444840 Exp.2020-09-03, (2) 19282BB UDI: 0084276803903419282BB20100810642444840 Exp. 2020-10-08, (3) 19330BD UDI:0084276803903419330BD20112510642444840 Exp. 2020-11-25. Expanded Recall: 3/10/21 20337AB, 20311BA, 20275AA, 20218AA, 20203BA, 20170AA, 20125BA, 20078AB.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0134-2021
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