Recall record at a glance
| Official record | Z-0026-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Becton Dickinson & Co. |
| Report date | Oct 16, 2024 |
| Recall initiation date | Sep 12, 2024 |
| Quantity | 162 units |
| Location | Sparks, MD, United States |
Official 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
Why the product was recalled
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 information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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