BD FACSLyric Flow Cytometer — Class II medical device recall Z-0070-2020
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2019-10-16, distributed in CA, CO, FL, GA, HI, IA, IL, IN…. Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic ab
| Recall number | Z-0070-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2019-08-19 |
| Classified | 2019-10-09 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2024-04-12 |
| Distributed | CA, CO, FL, GA, HI, IA, IL, IN, KS, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA, VT, WA |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CO, CZ, DE, DK, DZ, EC, ES, FI, FR, GB, HR, ID, IE, IL, IN, IQ, IR, IT, JP, KR, LT, LV, MX, MY, NL, PE, PL, QA, SA, SE, SG, SK, TR, TW, VN, ZA |
| Quantity | 21 |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00651164000025, 00651164000032 |
| Serial numbers | R651164000007, R651164000016, R651164000017, R651164000019, R651164000020, R651164000021, R651164000022, R651164000023, R651164000024, R651164000025, R651164000026, R651164000027, R651164000028, R651164000029, R651164000030, R651164000031, R651164000032, R651164000033, R651164000034, R651164000035, R651164000036 |
| Model numbers | 651164 |
Product
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0070-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.