BD Flow Cytometers
Medical device recall Z-2090-2015. Published in FDA’s Enforcement Report on Jul 22, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 22, 2015. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2188 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
2188 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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,…
Every code shown here, 1,999 characters
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 H47100193, 340551 H47100197, 643182 P18200019, 341360 P0324, 644655 00-00027-00, 643695 P69500082, 643695 P69500093, 338960 V96101018, 334079 P1003, 644655 Z65500010, 340551 H55100016, 650036 P03600001, 646500 X5000040, 649225 H5B400031, 650109 P10900001, 338960 V33896101581, 647177 H64717700006, 343020 E1774, 343202 E2583, 343268 SE0060, 644655 00-00023-00, 654899 V96100174, 340469 P46900074, 343276 E0511, 340469 P46900092, 340469 P46900091, 340551 H47100089, 338960 V96100546, 338960 V96100172, 342975 E97501071, 340551 H47100177, 643695 P69500103, 643695 P69500104, 340551 H47100229, 340551 H47100234, 647800 H80000006, 338962 V96301224, 643695 P69500081, 343020 E0337, 342975 E97500077, 342975 E97500509, 342975 E97500510, 342975 E97501195, 33717508 V0013, 337175 V07300219, 338962 V96301195, 333999 P99900028, 342975 E97500606, 338960 V96100320, 342973 E97300244, 342975 E97501014, 450500 D08932049, 342976 E97600314, 641548 V96100195, 340551 H47100030, 340551 H47100066, 340551 H47100111, 340551 H47100113, 338960 V96100602, 338960 V96100613, 340551…
FDA’s list runs to 38,296 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 15, 2015.
- FDA classified it on Jul 16, 2015.
- FDA’s Enforcement Report published it on Jul 22, 2015.
- FDA terminated it on Aug 12, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BD Biosciences, Systems & Reagents, of San Jose, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 38,296 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.