Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software
Class I - DangerousWhat Should You Do?
- Check if you have this product: A. C10574/UDI: 15099590705084 B. C10575/UDI: 15099590705091 C. C10576/UDI: 15099590705114 D. C10577/UDI: 15099590705107 E. C10578/UDI: 15099590705121 F. C10579/UDI: 15099590705138 G. C10580/UDI: 15099590705145 H. C10581/UDI: 15099590705152 I. C21166/UDI: 15099590705169
- 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:
- Beckman Coulter Inc.
- Reason for Recall:
- Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software
Product Codes/Lot Numbers:
A. C10574/UDI: 15099590705084 B. C10575/UDI: 15099590705091 C. C10576/UDI: 15099590705114 D. C10577/UDI: 15099590705107 E. C10578/UDI: 15099590705121 F. C10579/UDI: 15099590705138 G. C10580/UDI: 15099590705145 H. C10581/UDI: 15099590705152 I. C21166/UDI: 15099590705169
Distribution:
Distributed in: US, CA, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1982-2019
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