High FDA (Devices)·Z-0069-2020·Announced 2019-10-16

BD FACSLyric Flow Cytometer Recall for Potential False High Counts

Becton, Dickinson and Company is recalling 78 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 is classified as FDA Class II. The hazard involves a risk of harm through incorrect clinical decisions (e.g., unnecessary therapy or mismanagement) due to inaccurate data, but the source text does not report any actual injuries or illnesses, 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 78 units of the BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument (REF: 662878, and 66287808 when using BD Trucount Tubes). The recall affects specific serial numbers listed in the agency documentation. The devices were distributed across 26 U.S. states and numerous 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 the manufacturer for instructions on how to proceed.

The recalled product

Product: BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
Manufacturer: Becton, Dickinson and Company, BD Biosciences
Category: Medical Device — Laboratory Equipment
Hazard: inaccurate-data
clinical-decision-error
Affected units: 78

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: Z662878000003
Z662878000041
Z662878000042
Z662878000043
Z662878000044
Z662878000045
Z662878000046
Z662878000047
Z662878000049
Z662878000050
Z662878000051
Z662878000052
Z662878000053
Z662878000054
Z662878000055
Z662878000056
Z662878000057
Z662878000058
Z662878000059
Z662878000060

Distribution

Distributed in 26 states:

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 →

Same manufacturer · Becton, Dickinson and Company, BD Biosciences

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Same hazard · inaccurate data