Recall Z-0026-2025 ยท JQP Calculator/Data Processing Module, For Clinical Use
Becton Dickinson & Co.
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
| Date | Oct 8, 2024 (initiated Sep 12, 2024) |
| Status | Open, Classified |
| Reason | Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false r |
| Root cause | Under Investigation by firm |
| Action | BD issued Urgent Medical Device Correction letter on 12Sep2024. Letter states reason for recall, health risk and action to take: 1.Immediately identify if you have the affected software version noted in the affected product tableabove. Reference Attachment 2 for software version verification instructions. 2.Determine if the feature is active in your system by reviewing the system settings. Refer toAttachment 3 for System settings breakpoint feature instructions. 3.If the inline breakpoint feature is enabled, please disable the feature and keep disabled untilupgraded to Synapsys" software versi |
| Quantity | 162 units |
| Distribution | Nationwide Foreign: Australia, New Zealand, Singapore, Hong Kong, Taiwan, Japan, Austria, Belgium, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, Russia, Saudi Arabia, South Africa, Canada, Mexico, China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.