BD FACSLyric Flow Cytometer Recall for Potential False High Absolute Counts
Becton, Dickinson and Company is recalling 236 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.
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 is classified as FDA Class II, and the defect poses a risk of harm through incorrect clinical decisions (such as unnecessary therapy or transfusion) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton, Dickinson and Company, BD Biosciences is recalling 236 units of the BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument (REF: 659180 and 65918001). The recall applies specifically to instruments used with BD Trucount Tubes. The affected units were distributed across 26 U.S. states and 44 foreign countries.
The recall is due to a potential defect where the flow cytometers may experience excessive electronic abort counts when used with the 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.
The inaccurate 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 proceed with the recall.
The recalled product
- Product
- BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Affected units
- 236
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: 9180000057
- 9180000219
- 9180000283
- 0000001R6591800
- R658180000282
- R6591800000082
- R6591800000083
- R659180000045
- R659180000051
- R659180000061
- R659180000063
- R659180000064
- R659180000068
- R659180000071
- R659180000075
- R659180000089
- R659180000099
- R659180000137
- R659180000167
- R659180000196
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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