Class 2 Device Recall BD FACSLyric Flow Cytometer

• Date Initiated by Firm: August 19, 2019
• Create Date: October 09, 2019
• Recall Status: Terminated on April 12, 2024
• Recall Number: Z-0074-2020
• Recall Event ID: 83603
• 510(K)Number: K170974
• Product Classification: Flow cytometric reagents and accessories. - Product Code OYE
• Product: BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
• Code Information: 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, R659180000160, R659180000238.
• Recalling Firm/ Manufacturer: Becton, Dickinson and Company, BD Biosciences; 2350 Qume Dr; San Jose CA 95131-1812
• For Additional Information Contact: 408-954-2100
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 22
• Distribution: U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OYE and Original Applicant = Becton, Dickinson and Company