UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are…
Medical device recall Z-0147-2014. Published in FDA’s Enforcement Report on Nov 13, 2013.
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 Nov 13, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 1,025 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 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?
Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company’s internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.
1,025 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Numbers: 629029 for DxH 800 and B23858 for DxH 600. Serial Numbers: AS49437 AV11229 AV23436 AV28032 AT05062 AU32435 AT27373 AT09132 AV06132 AV06143 AT21266 AT21268 AT23307 AS46410 AS46411 AU48003 AV05097 AT27346 AT40554 AU23277…
Every code shown here, 1,993 characters
Part Numbers: 629029 for DxH 800 and B23858 for DxH 600. Serial Numbers: AS49437 AV11229 AV23436 AV28032 AT05062 AU32435 AT27373 AT09132 AV06132 AV06143 AT21266 AT21268 AT23307 AS46410 AS46411 AU48003 AV05097 AT27346 AT40554 AU23277 AV05082 AV05092 AV11205 AT06076 AT09112 AT09114 AT16214 AT18235 AV11214 AV11217 AN30069 AS07008 AT09116 AS40361 AU05048 AU05054 AT48658 AS49426 AS49429 AV01023 AV01025 AM48043 AV06003 AT40542 AS15064 AT30380 AV01015 AS12050 AV06004 AV06151 AS12051 AS12052 AT01004 AU25303 AT36497 AT36499 AT36509 AV06127 AV06130 AV11231 AV14273 AV14275 AV27546 AV06141 AV01009 AV05104 AV09187 AV09192 AV09179 AU42632 AV06152 AV11238 AV14278 AV14283 AV28554 AV28559 AV23449 AV18362 AV09180 AV18364 AV24456 AV22393 AV11234 AV02072 AV05098 AV09184 AV02046 AV09191 AV09196 AV09197 AV24452 AT18242 AV09182 AV02051 AV02068 AV02076 AV06139 AV11236 AV12241 AV14287 AV28031 AV06147 AV11216 AV24490 AV26492 AV26498 AV26499 AS46412 AV12265 AV14266 AV05093 AV01032 AV14288 AV18373 AV26506 AV27512 AV02042 AU06070 AV06150 AV23424 AV26491 AV26495 AV26496 AV26500 AV26501 AV26503 AV26504 AV26505 AV27514 AV02064 AV18371 AV18375 AV01029 AV01031 AS43391 AS43392 AV01006 AV11232 AV23419 AV23423 AV28026 AV16315 AV16326 AN10031 AV01002 AV14294 AV18359 AV18365 AV27541 AV12260 AV05117 AV05120 AV27533 AV06154 AV06157 AV22386 AV28028 AV28595 AT44622 AV11202 AV27542 AV28564 AV22388 AT24332 AT27337 AV24467 AT42590 AV02044 AV02052 AV05095 AV05107 AV05109 AT27347 AN10025 AN20049 AS40359 AV12245 AV12247 AS24192 AV16337 AV16339 AU47779 AV14271 AN30064 AN30070 AV24457 AV24458 AV27537 AT02042 AU40574 AV14295 AT48660 AV23422 AT27343 AV28561 AN07022 AN10027 AT27345 AV02061 AT23288 AN42123 AT21265 AV27544 AV02070 AT18248 AV16336 AV06148 AV11221 AV11227 AV01008 AU05052 AV18358 AV18369 AV24465 AV24466 AV05096 AV01035 AV01038 AT23274 AV05099 AV18349 AV18366 AV28033 AV23439 AV24455 AV28029 AV28030 AU02003 AV05085 AV06140 AV22407 AV23430 AV27524 AV27528 AV28580 AV09172 AS27199 AS27204 AS27221 AS27222…
FDA’s list runs to 8,264 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.
Worldwide distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Macao, Netherlands, New Zealand, Panama, Poland, Portugal Qatar, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Trindad and Tobago, Turkey, United Arab Emirates, and United Kingdom. .
The states and territories these words name
- Puerto Rico
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.
The words say it went outside the United States too.
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 Sep 24, 2013.
- FDA classified it on Nov 4, 2013.
- FDA’s Enforcement Report published it on Nov 13, 2013.
- FDA terminated it on Apr 21, 2014.
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 8,264 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.