FDA Device recall Z-2090-2015
BD Flow Cytometers
- FDA Device
- Class III
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class III recall of BD Flow Cytometers by Bd Biosciences Systems And Reagents, citing instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance w….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2090-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-06-15 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bd Biosciences Systems And Reagents |
| Distribution | US |
Product
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
Reason
Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).
Identifiers
| code_info | Material No. Serial No. 343202 E0565, 343202 E3190, 338960 V96100212, 338962 V96300187, 338962 V96300189, 342975…Material No. Serial No. 343202 E0565, 343202 E3190, 338960 V96100212, 338962 V96300187, 338962 V96300189, 342975 E97500564, 338962 V96300231, 342975 E97500700, 33300472 H47200110, 338962 V96300567, 338960 V96100817, 338960 V96100911, 338960 V96100913, 338962 V96300761, 338960 V96101255, 648063 H06300007, 647793 H79300005, 343276 E4731, 337175 V07300249, 647785 H64778500001, 647793 H64779300011, 338960 V33896101603, 338962 V33896301405, 340128 W91100061, 340128 W91100104, 343202 E0035, 343202 E0108, 343202 E0692, 343202 E0849, 343202 E3313, 343202 E3355, 343023 E0722, 343023 E1312, 343023 E3108, 654899 V96101131, 340469 P46900047, 644655 00-00059-00, 340551 H47100064, 644655 00-00068-00, 340469 P46900070, 341360 P22300058, 342975 E97500699, 340469 P46900093, 644655 00-00065-00, 643695 P69500019, 340551 H47100133, 643178 P17800016, 643695 P69500029, 643695 P69500031, 338960 V96100758, 340551 H47100171, 340551 H47100180, 340551 H471001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2090-2015%22
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