Recall notification - BD FACSLyric, BD FACSVerse

Aug 19, 2019


BD FACSLyric Flow Cytometer

BD has confirmed that some BD FACSLyric Flow Cytometers experience higher than expected absolute counts when using BD Trucount tubes. Excessive electronic abort counts may affect the ratio of cell population events to bead events, potentially resulting in a falsely high absolute count.

BD Multitest with or without BD Trucount tubes are intended for use with FACSLyric for the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of mature human lymphocyte subsets: T, B, and NK cells.

When using the BD Multitest reagent for CD4 absolute counts in HIV patients, a falsely high CD4 count may cause a delay in initiation of prophylactic therapy for Opportunistic Infections (OIs). Current clinical guidelines1 use a combination of HIV viral load, CD4 absolute counts, and other disease sequelae for the overall evaluation of a patient’s disease burden and subsequent clinical management.

There is also a potential for falsely high absolute cell counts from samples stained with BD Multitest™ reagent which may result in an erroneous assessment of the immune function for Primary Immune Deficiency (PID) initial screening, or immune suppressive therapy management. For PID and immune suppressed patients (post-organ or stem cell transplantation), the assessment of the T-, B- and NK subpopulation as part of the initial screening or ongoing monitoring has the potential to affect decisions regarding care and management.

Excessive abort counts may also affect laboratory developed tests (LDT) or experiments that determine the absolute count of cell populations using BD Trucount™ tubes. This may result in falsely high absolute counts.

When performing a stem cell enumeration test using BD Trucount tubes as an LDT, the absolute count of stem cells is used to assess the quality of the transplant product for stem cell transplantation. Falsely high absolute counts may affect the specimen engraftment potency. For leucoreduced blood product testing using BD Trucount tubes with propidium iodide as an LDT to identify residual nucleated cells, a falsely high number of residual cell counts may prevent the use of the leucoreduced blood products for transfusion

BD FACSVerse Flow Cytometer

BD has confirmed that some BD FACSVerse Flow Cytometers experience higher than expected absolute counts when using BD Trucount tubes. Excessive electronic abort counts may affect the ratio of cell population events to bead events, potentially resulting in a falsely high absolute count.

Excessive abort counts may affect laboratory developed tests (LDT) or experiments that determine the absolute count of cell populations using BD Trucount tubes. This may result in falsely high absolute counts. Any laboratories that use other products for determining absolute counts should evaluate their results.

The recall was specific to certain FACSLyric and FACSVerse instrument serial numbers.  All customers were contacted directly.

If you require further assistance, please contact BD Customer/Technical Support at 844-918-0554.

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