UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System
Medical device recall Z-2732-2016. Published in FDA’s Enforcement Report on Sep 14, 2016.
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 Sep 14, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Puerto Rico the one state its words name
- 5,282 units total (2,877 units in US) 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
5,282 units total (2,877 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. AZ28848 AZ20791 AZ20789 AZ25359 AZ25362 AM51052 AZ23820 AZ28405 AZ28406 AZ02009 AW23066 AW16273 AW02003 AV52153 AU44687 AU44682 AV09188 AY50973 AZ25374 AV09197 AZ03660 AZ06661 AW23164 AY10661 AT48671 AY17706 AV11202 AS24187…
Every code shown here, 1,995 characters
Serial No. AZ28848 AZ20791 AZ20789 AZ25359 AZ25362 AM51052 AZ23820 AZ28405 AZ28406 AZ02009 AW23066 AW16273 AW02003 AV52153 AU44687 AU44682 AV09188 AY50973 AZ25374 AV09197 AZ03660 AZ06661 AW23164 AY10661 AT48671 AY17706 AV11202 AS24187 AU42604 AU42605 AU47775 AU47783 AU45705 AW02013 AT09135 AT18249 AT18247 AW05068 AW02059 AW12090 AU19248 AU19249 AU19248 AW02020 AV35049 AV38713 AU36511 AU36519 AY17711 AY04037 AY01034 AY17198 AV28561 AZ28855 AY42926 AY42921 AU44671 AY24762 AY24768 AU36524 AW16124 AW14113 AW45310 AV09167 AW26208 AV44863 AW35273 AW35269 AW23085 AZ12149 AU47757 AV44103 AW23167 AW20160 AW31265 AW31263 AV32042 AW23060 AW23061 AV49123 AV14278 AV14283 AZ12183 AZ12182 AU38543 AU40576 AV06152 AU42632 AZ10095 AZ10107 AZ12140 AZ12141 AZ12165 AZ12166 AV27520 AV27522 AW51368 AZ12146 AZ12145 AZ12148 AZ12147 AV28609 AV28610 AZ12151 AZ12153 AZ10109 AZ10101 AZ06687 AZ19767 AW16135 AW20152 AS07010 AS07024 AS07025 AW31250 AY06635 AY08646 AU49788 AU47779 AY01606 AW51367 AW51366 AY21742 AY19734 AV14297 AV24463 AV24462 AZ16736 AY33822 AW04034 AY40896 AZ02605 AZ02601 AY52691 AY52692 AY28792 AY30802 AY30800 AY30799 AV02047 AV02048 AV16314 AV16318 AS12049 AS12048 AU36491 AU36509 AV28573 AV28587 AV28586 AV28607 AY42915 AV27512 AV26506 AY40903 AY40904 AT40549 AT40548 AW23168 AV09191 AV09196 AW14260 AZ23348 AZ23344 AV18346 AT23304 AT31426 AT31411 AY28349 AV01006 AV16342 AU49795 AU49816 AU49809 AU49796 AU49794 AU49806 AU49797 AZ06681 AU49807 AU49805 AZ12706 AV50129 AT48660 AT48657 AV09172 AV44853 AV44862 AU47769 AY01022 AT12164 AT12174 AN42122 AY19722 AU04021 AU02008 AU45700 AU44684 AU32440 AU32445 AU44679 AU44677 AU36494 AU36498 AZ20796 AT27348 AV16321 AV37063 AU05046 AU05045 AW02011 AZ23819 AW23162 AY36860 AY38867 AU44686 AU44691 AV12245 AV12247 AU40571 AU40564 AU40574 AU40568 AV16339 AV16337 AV14295 AV05109 AV05107 AS07027 AV02061 AV18371 AV18375 AN49155 AT40561 AV47877 AW29221 AU14164 AW14250 AW10065 AW26102 AW26104 AU05053 AY45937 AW04039 AW04038 AS36311 AS36310 AW06054…
FDA’s list runs to 24,921 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.
Affected geographies: Andorra, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, Egypt, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.
The states and territories these words name
- Puerto Rico
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Aug 8, 2016.
- FDA classified it on Sep 2, 2016.
- FDA’s Enforcement Report published it on Sep 14, 2016.
- FDA terminated it on Apr 29, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter Inc., of Brea, 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 24,921 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
-
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.