Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
Brand
Becton, Dickinson and Company, BD Biosciences
Lot Codes / Batch Numbers
BD FACSLyric Flow Cytometer serial numbers: Z662877000001, Z662877000002, Z662877000003, Z662877000004, Z662877000005, Z662877000006, Z662877000007, Z662877000008.
Products Sold
BD FACSLyric Flow Cytometer serial numbers: Z662877000001, Z662877000002, Z662877000003, Z662877000004, Z662877000005, Z662877000006, Z662877000007, Z662877000008.
Becton, Dickinson and Company, BD Biosciences is recalling BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes due to Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.
Recommended Action
Per FDA guidance
On 08/19/19, the recalling firm started calling and distributing Urgent Medical Device Recall notices to customers. Laboratory managers were asked to do the following: 1) Run the Abort Count Quantification Protocol. 2) Record the percentage of aborted events on the attached Customer Response Form and submit via fax, email, or online to the recalling firm regardless of the result. 3) For percent aborted events less-than 1.0 percent: your instrument is performing as expected and no further action is required once the percent aborted events has been provided to via Customer Response Form. 4) For percent aborted events greater-than-or-equal-to 1.0 percent: suspend all patient testing. A Technical Representative will contact you within 24 hours (Mon-Fri) of receiving the data (response form) to schedule a service visit. 5) Refer to the Frequently Asked Questions document for more information. Recalling firm is investigating the root cause and to identify actions to prevent recurrence. Customers with additional questions are encouraged to call: Customer/Technical Support at 844-918-0554.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, GA, HI, IL, IN, IA, KS, MD, MA, MI, MN, MO, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VT, VA, WA
Page updated: Jan 10, 2026