Agency classClass IIOur severity:High FDA (Devices)·Z-0068-2020·Announced 2019-10-16

BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

Becton, Dickinson and Company is recalling eight BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.

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 is classified as FDA Class II, and the hazard involves a risk of harm to patients through inaccurate diagnostic results that could lead to incorrect clinical management, without reported injuries or fatalities.

Plain-English summary

Becton, Dickinson and Company, BD Biosciences is recalling eight units of the BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument (REF: 662877). The recall applies specifically to these instruments when they are used with BD Trucount Tubes. The affected units are identified by serial numbers Z662877000001 through Z662877000008.

The recall is due to a potential issue where the flow cytometers may experience excessive electronic abort counts when used with specific tubes. This issue may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. These inaccurate results may impact 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.

The affected products were distributed in the United States and in numerous foreign countries. Users of these specific instruments should contact Becton, Dickinson and Company for further instructions regarding the recall and potential replacement or repair.

The recalled product

Product: BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
Manufacturer: Becton, Dickinson and Company, BD Biosciences
Category: Medical Device — Laboratory Equipment
Hazard: inaccurate-results
mis-diagnosis
Affected units: 8

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 (8)

BD FACSLyric Flow Cytometer serial numbers: Z662877000001
Z662877000002
Z662877000003
Z662877000004
Z662877000005
Z662877000006
Z662877000007
Z662877000008.

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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