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Z-0026-2025 Class II Ongoing

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-0026-2025 was initiated by Becton Dickinson & Co. on Sep 12, 2024 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 162 units.

Recall Details

Product Type: Devices
Report Date: Oct 16, 2024
Initiation Date: Sep 12, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 162 units

Product Description

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

Reason for Recall

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 resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy

Distribution Pattern

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

Code Information

UDI-DI: 00382904441500 Software versions: 4.20, 4.30, 5.10, 5.20 and 5.30

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0026-2025
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

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