Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: 6EQH01, 6EQH01A, 6EQH01B, 6EQH01C (exp. date 2017-09-17); 6LQH01A, 6LQH01B, 6LQH01C (exp. date 2018-04-04). --- Lot # (UDI): 6EQH01 (008427680063576EQH0120170917), 6EQH01A (008427680063576EQH01A2017091), 6EQH01B(008427680063576EQH01B20170917), 6EQH01C(008427680063576EQH01C20170917), 6LQH01A (008427680063576LQH01A20180404), 6LQH01B (008427680063576LQH01B20180404), 6LQH01C (008427680063576LQH01C20180404).
- 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:
- Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
- 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 Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
Product Codes/Lot Numbers:
Lot numbers: 6EQH01, 6EQH01A, 6EQH01B, 6EQH01C (exp. date 2017-09-17); 6LQH01A, 6LQH01B, 6LQH01C (exp. date 2018-04-04). --- Lot # (UDI): 6EQH01 (008427680063576EQH0120170917), 6EQH01A (008427680063576EQH01A2017091), 6EQH01B(008427680063576EQH01B20170917), 6EQH01C(008427680063576EQH01C20170917), 6LQH01A (008427680063576LQH01A20180404), 6LQH01B (008427680063576LQH01B20180404), 6LQH01C (008427680063576LQH01C20180404).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0176-2018
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