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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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
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.
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