BD Synapsys Informatics Solution, Catalog Number 444150
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00382904441500;
- 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:
- Becton Dickinson & Co.
- Reason for Recall:
- There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final Discard, Mark as Read, Save) to process patient results rapidly.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
BD Synapsys Informatics Solution, Catalog Number 444150
Product Codes/Lot Numbers:
UDI-DI: 00382904441500;
Distribution:
Distributed in: US, CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2099-2023
Related Recalls
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
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The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.