BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts
Becton, Dickinson and Company is recalling 30 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes, potentially affecting clinical decisions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, as the defect may lead to incorrect clinical decisions and treatment.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences, is recalling 30 units of the BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument (REF: 654587). The recall applies specifically to instruments used with BD Trucount Tubes. The affected units are distributed across 26 U.S. states and 43 foreign countries.
The recall is due to a potential defect where the flow cytometers may experience excessive electronic abort counts when used with specific tubes. This issue can affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. The source text does not report any illnesses or injuries associated with this defect.
Falsely high absolute counts may impact clinical decisions, including the initiation of prophylactic therapy for opportunistic infections in HIV patients, care management for immune-suppressed patients, laboratory developed tests, specimen engraftment potency, and the use of leucoreduced blood products for transfusion. Users should contact Becton, Dickinson and Company for instructions on how to address the issue.
The recalled product
- Product
- BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- BD FACSLyric Flow Cytometer serial numbers: R654587000008
- R654587000009
- R654587000010
- R654587000011
- R654587000024
- R654587000026
- R654587000027
- R654587000028
- R654587000029
- R654587000030
- R654587000031
- R654587000032
- R654587000033
- R654587000034
- R654587000035
- R654587000036
- R654587000037
- R654587000038
- R654587000039
- R654587000040
Distribution
Part of a larger recall action
This product is one of 9 recalled by Becton, Dickinson and Company, BD Biosciences under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Becton, Dickinson and Company, BD Biosciences
See all →- HighBD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results
FDA (Devices) · 2024-07-24
- HighMedical diagnostic reagent recall: incorrect cell staining fluorescence
FDA (Devices) · 2024-01-17
- HighBD Trucount Tubes for Blood Testing Recall Due to Label Detachment
FDA (Devices) · 2022-11-09
- HighBD Trucount Tubes Recalled Due to Partial Label Detachment Causing Operational Failures
FDA (Devices) · 2022-11-09
- ModerateBD Multitest 6-Color TBNK tubes recalled for partial label detachment
FDA (Devices) · 2022-11-09
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06