BD FACSLyric Flow Cytometer Recalled for Potential False High Counts
Becton, Dickinson and Company is recalling 12 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific 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 high-risk medical device where the defect poses a risk of harm through incorrect clinical decisions, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling 12 units of the BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument (REF: 662875). The recall applies to specific serial numbers listed in the agency's documentation. The devices were distributed to facilities in 26 U.S. states and 41 foreign countries.
The recall is due to a defect where the flow cytometers, when used with BD Trucount Tubes, may experience excessive electronic abort counts. This issue can alter 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.
These inaccurate counts may affect clinical decisions, including the initiation of prophylactic therapy for opportunistic infections in HIV patients, care management for immunosuppressed patients, laboratory developed tests, specimen engraftment potency, and the use of leucoreduced blood products for transfusion. Users should contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 12
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 (12)
- BD FACSLyric Flow Cytometer serial numbers: Z662875000001
- Z662875000007
- Z662875000008
- Z662875000009
- Z662875000011
- Z662875000012
- Z662875000013
- Z662875000014
- Z662875000015
- Z662875000016
- Z662875000017
- Z662875000018.
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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