BD FACSLyric Flow Cytometer Recalled for Potential False Absolute Counts
Becton, Dickinson and Company is recalling specific BD FACSLyric Flow Cytometers used with BD Trucount Tubes due to potential electronic errors that may result in falsely high absolute cell counts.
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, and the defect could lead to incorrect clinical management decisions for vulnerable patient populations.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences, is recalling the BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument (REF: 662876) when used with BD Trucount Tubes. The recall is limited to the unit with serial number Z662876000007. The device was distributed in 26 U.S. states and 41 foreign countries.
The recall is issued because the flow cytometer 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.
Affected users may experience impacts on 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 the recalling firm for further instructions.
The recalled product
- Product
- BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 1
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 (1)
- BD FACSLyric Flow Cytometer serial number: Z662876000007.
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.
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