BD Flow Cytometers — Class III medical device recall Z-2090-2015

Terminated recall by BD Biosciences, Systems & Reagents, reported 2015-07-22, distributed nationwide. Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Dr

Recall number	`Z-2090-2015`
Product type	Medical device
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	BD Biosciences, Systems & Reagents, San Jose, CA, United States
Recall initiated	2015-06-15
Classified	2015-07-16
Reported by FDA	2015-07-22
Terminated	2016-08-12
Distributed	Nationwide (US)
Quantity	2,188 units
Reason classes	labeling
UPC / GTIN / UDI-DI	`03405510000040`
Serial numbers	`00-00002-00`, `00-00022-00`, `00-00023-00`, `00-00025-00`, `00-00026-00`, `00-00027-00`, `00-00042-00`, `00-00053-00`, `00-00058-00`, `00-00059-00`, `00-00063-00`, `00-00065-00`, `00-00068-00`, `00-00071-00`, `00-00075-00`, `00-00078-00`, `00-00079-00`, `00-00082-00`, `00-00086-00`, `1201-46196-A054`, `333004`, `33300471`, `33300472`, `33300476`, `33300478` and 475 more

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 for recall

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).

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-2090-2015. 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.