Agency classClass IIOur severity:High FDA (Devices)·Z-0072-2020·Announced 2019-10-16

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Laboratory Equipment
Hazard: inaccurate-results
clinical-decision-error
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

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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