Agency classClass IIOur severity:Severe FDA (Devices)·Z-0074-2020·Announced 2019-10-16

BD FACSLyric Flow Cytometers Recalled for Potential False High Counts

Becton, Dickinson and Company is recalling 22 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a defect that can lead to falsely high absolute counts, potentially affecting critical clinical decisions and patient care for immune-suppressed individuals.

Plain-English summary

Becton, Dickinson and Company, BD Biosciences, is recalling 22 units of the BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument (REF: 663029). The recall applies specifically to instruments used with BD Trucount Tubes. The affected units are distributed across 26 U.S. states and 42 foreign countries.

The recall is due to a 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. These inaccurate results may impact clinical decisions, including the initiation of prophylactic therapy for opportunistic infections in HIV patients, care management for immune-suppressed patients, and the use of leucoreduced blood products for transfusion.

The recall is classified as FDA Class II. No specific instructions for consumers are provided in the source text, but the recall number is Z-0074-2020.

The recalled product

Product: BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
Manufacturer: Becton, Dickinson and Company, BD Biosciences
Category: Medical Device — Flow Cytometer
Hazard: inaccurate-results
clinical-decision-error
Affected units: 22

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: R663029000001
R663029000002
R663029000003
R663029000004
R663029000005
R663029000006
R663029000007
R663029000008
R663029000010
R663029000011
R663029000012
R663029000014
R663029000015
R663029000016
R663029000017
R663029000018
R663029000021
R663029000025
R663029000031
R659180000136

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 results