The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0070-2020·Announced 2019-10-16

BD FACSLyric Flow Cytometers Recalled for Potential False High Absolute Counts

Becton, Dickinson and Company is recalling 21 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific 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 is classified as FDA Class II. The hazard involves a risk of harm through incorrect clinical decisions (such as unnecessary therapy or transfusion issues) without reported illnesses or injuries, which aligns with 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 21 units of the BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument (REF: 651164). The recall applies specifically to instruments used with BD Trucount Tubes. The affected units are distributed across 26 U.S. states and 41 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 affect 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. Affected serial numbers are listed in the source metadata.

The recalled product

Product
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
Manufacturer
Becton, Dickinson and Company, BD Biosciences
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
21

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: R651164000007
  • R651164000016
  • R651164000017
  • R651164000019
  • R651164000020
  • R651164000021
  • R651164000022
  • R651164000023
  • R651164000024
  • R651164000025
  • R651164000026
  • R651164000027
  • R651164000028
  • R651164000029
  • R651164000030
  • R651164000031
  • R651164000032
  • R651164000033
  • R651164000034
  • R651164000035

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 →

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