Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Becton Dickinson & Co.: Synapsys Software Recalled for Incorrect Antibiotic Breakpoint Displays

Agency Publication Date: October 8, 2024
Share:
Sign in to monitor this recall

Summary

Becton Dickinson & Co. is recalling 162 units of BD Synapsys Informatics Solution software versions 4.20, 4.30, 5.10, 5.20, and 5.30 due to a software error in the in-line breakpoint feature. The software may incorrectly display antibiotic sensitivity results for certain organisms that do not have defined standards, potentially leading to false susceptible or false resistant reports. This defect can result in patients receiving ineffective antibiotic treatments or being denied preferred therapies. Consumers should contact their healthcare provider or Becton Dickinson & Co. to ensure their laboratory software is updated or patched to correct this error.

Risk

The software error can cause medical professionals to misinterpret how effective an antibiotic will be against an infection. This may lead to the use of an ineffective drug (false susceptible) or the unnecessary avoidance of a preferred treatment (false resistant), which can cause inadequate treatment or prolonged illness.

What You Should Do

  1. Verify if your laboratory is utilizing BD Synapsys Informatics Solution software versions 4.20, 4.30, 5.10, 5.20, or 5.30 by checking the software version information screen within the application.
  2. Check the 'in-line breakpoint' feature settings to determine if your system is currently displaying interpretive results for organisms without defined CLSI or EUCAST breakpoints.
  3. Review clinical reports for any instances where organisms were grouped with different species for interpretive results, as these may contain false susceptibility or resistance data.
  4. Contact Becton Dickinson & Co. (BD) at their Sparks, Maryland headquarters or through your local BD service representative to obtain the necessary software patch or update instructions.
  5. Consult with your healthcare provider or laboratory director to discuss any potential impact on patient treatment regimens based on previous software outputs.
  6. For additional information or assistance, contact Becton Dickinson & Co. or call the FDA's medical device recall hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Software update or patch

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BD Synapsys Informatics Solution (Software versions 4.20, 4.30, 5.10, 5.20 and 5.30)
Model / REF:
Catalog Number: 444150
UPC Codes:
00382904441500

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95394
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Becton Dickinson & Co.; Clinical laboratories
Manufactured In: United States
Units Affected: 162 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.