High FDA (Devices)·Z-0071-2020·Announced 2019-10-16

BD FACSLyric Flow Cytometer Recall for Potential Inaccurate Cell Counts

BD Biosciences is recalling 36 BD FACSLyric Flow Cytometers because they may produce falsely high absolute cell counts when used with BD Trucount 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 and involves a risk of harm to patients through inaccurate diagnostic results that could lead to incorrect clinical management, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Becton, Dickinson and Company, BD Biosciences, is recalling 36 units of the BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument (REF: 651165). The recall applies specifically when the instrument is used with BD Trucount Tubes. The affected units are 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 of beads. This issue can alter the ratio of cell population events to bead events, resulting in falsely high absolute counts. Inaccurate results may impact clinical decisions, including the initiation of prophylactic therapy for opportunistic infections in HIV patients, care management for immunosuppressed patients, and the use of leucoreduced blood products for transfusion.

Healthcare facilities and laboratories should stop using the affected instruments with BD Trucount Tubes and contact BD Biosciences for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, 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: 36

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: R651165000010
R651165000023
R651165000024
R651165000025
R651165000026
R651165000027
R651165000028
R651165000029
R651165000030
R651165000031
R651165000032
R651165000033
R651165000034
R651165000035
R651165000036
R651165000037
R651165000038
R651165000039
R651165000040
R651165000041

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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