Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: 6JC001, 6JC001C, 6JC001G (exp. date 2018-01-11); 6MC001, 6MC001C (exp. date 2018-04-29); 6CC001A, 6CC001B, 6CC001F (exp. date 2017-07-14); 6FC001A, 6FC001C, 6FC001E (exp. 2017-10-27); --- Lot # (UDI): 6CC001A (008427680244436CC001A20170714), 6CC001B (008427680244436CC001B20170714), 6CC001F (008427680244436CC001F20170714), 6FC001A (008427680244436FC001A20171027), 6FC001C (008427680244436FC001C20171027), 6FC001E (008427680244436FC001E20171027), 6JC001 (008427680244436JC00120180111), 6JC001C (008427680244436JC001C20180111), 6JC001G (008427680244436JC001G20180111), 6MC001 (008427680244436MC00120180429), 6MC001C (008427680244436MC001C20180429).
- 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 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
Product Codes/Lot Numbers:
Lot numbers: 6JC001, 6JC001C, 6JC001G (exp. date 2018-01-11); 6MC001, 6MC001C (exp. date 2018-04-29); 6CC001A, 6CC001B, 6CC001F (exp. date 2017-07-14); 6FC001A, 6FC001C, 6FC001E (exp. 2017-10-27); --- Lot # (UDI): 6CC001A (008427680244436CC001A20170714), 6CC001B (008427680244436CC001B20170714), 6CC001F (008427680244436CC001F20170714), 6FC001A (008427680244436FC001A20171027), 6FC001C (008427680244436FC001C20171027), 6FC001E (008427680244436FC001E20171027), 6JC001 (008427680244436JC00120180111), 6JC001C (008427680244436JC001C20180111), 6JC001G (008427680244436JC001G20180111), 6MC001 (008427680244436MC00120180429), 6MC001C (008427680244436MC001C20180429).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0173-2018
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