Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number:15037MA; ExpDate: 2016-07-14 Lot # 15175MA; ExpDate: 2015-11-17; Lot # 15204MA; Expdate: 2017-01-13; Lot #15246MA; expdate: 2017-02-26 Lot # 15267MA; expdate: 2017-02-26
- 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:
- customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Product Codes/Lot Numbers:
Lot Number:15037MA; ExpDate: 2016-07-14 Lot # 15175MA; ExpDate: 2015-11-17; Lot # 15204MA; Expdate: 2017-01-13; Lot #15246MA; expdate: 2017-02-26 Lot # 15267MA; expdate: 2017-02-26
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2450-2015
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