Z-0070-2020Class II

BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes

Name: Z-0070-2020 BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2019-08-19
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2019-08-19 / Terminated

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes on 2019-08-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0070-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-19
Posted: 2019-10-09
Terminated: 2024-04-12
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
Product code: OYE Flow Cytometric Reagents And Accessories.
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 root 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: 21
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
Product codes and lots: 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, R651164000036.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0070-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0066-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0067-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0068-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0069-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0070-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0071-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0072-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0073-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09
Z-0074-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-09

Product code OYE

K170974Class IIBD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company / cleared 2017-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)