FDA Devices recall · Reported February 13, 2019
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamli
A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows…
Becton, Dickinson and Company, Bd Biosciences recalled BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD F… - a low-severity action.
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD F… was recalled by Becton, Dickinson and Company, Bd Biosciences in February 13, 2019. Reason: A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on…. Check the official notice for the remedy. Verify recall #Z-0792-2019 with the FDA Devices before acting.
The recall
Becton, Dickinson and Company, Bd Biosciences issued this low-severity FDA Devices recall-A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on….
- Low
- severity level
- 3 units
- affected scope
- Class III
- classification
- February 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0792-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.
Reason for recall
A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for research use only.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0792-2019 |
| Date reported | February 13, 2019 |
| Date initiated | January 2, 2019 |
| Recalling firm | Becton, Dickinson and Company, Bd Biosciences |
| Firm location | San Jose, CA |
| Affected scope | 3 devices |
| Distribution | US Distribution in MD. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0792-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026