UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
Medical device recall Z-2692-2016. Published in FDA’s Enforcement Report on Sep 7, 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 7, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 759 units total (358 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?
Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear
759 units total (358 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
AZ28094 AW01001 AY01010 AY04011 AW20069 AV14059 AZ12033 AZ12034 AZ06021 AY52153 AV01003 AT40021 AV22105 AV12048 AZ12039 AU01015 AU40218 AU40217 AV22099 AU36203 AU36202 AV01012 AW35121 AW35120 AY08031 AU40222 AU11071 AV01008 AY52154 AY52152…
Every code shown here, 2,000 characters
AZ28094 AW01001 AY01010 AY04011 AW20069 AV14059 AZ12033 AZ12034 AZ06021 AY52153 AV01003 AT40021 AV22105 AV12048 AZ12039 AU01015 AU40218 AU40217 AV22099 AU36203 AU36202 AV01012 AW35121 AW35120 AY08031 AU40222 AU11071 AV01008 AY52154 AY52152 AY23080 AV16090 AT49047 AV42151 AV44158 AY10040 AW20067 AW16061 AU40221 AU11070 AW28093 AW10045 AV16079 AV14065 AU01032 AV10042 AU49257 AZ08032 AW23075 AY17061 AY17063 AW35124 AU21134 AW42129 AW20065 AY04013 AU14087 AV48179 AV49181 AW49163 AY01009 AZ22072 AW01010 AU19114 AT35018 AT35017 AT40020 AV06026 AV06030 AY19075 AU08046 AU29170 AU01027 AT49051 AV49183 AZ02004 AZ06022 AU43236 AU20131 AU01005 AU01004 AV01016 AU14086 AW01015 AW06026 AW06024 AV16085 AU01029 AZ02010 AU19116 AZ22073 AZ22074 AZ12041 AZ12042 AZ25090 AZ28091 AY30082 AY30083 AY10054 AY10037 AY04015 AY32106 AY10055 AV01005 AU23152 AU28154 AY35118 AU20123 AU36204 AU13078 AW45141 AY41137 AU28159 AY35110 AU08045 AU08042 AV27119 AV39133 AU16106 AV36129 AV36130 AY01006 AW49162 AV48178 AU30179 AU35188 AW16053 AU36193 AV48177 AU11051 AW20064 AW35113 AU35187 AU28162 AV40142 AV12052 AU11063 AV21094 AY32094 AU43226 AV10035 AV01004 AV01007 AY01002 AY01004 AZ20070 AU20124 AU01017 AU01021 AU14083 AU16104 AU01031 AZ24084 AV06024 AU30175 AU11066 AU19121 AU08044 AZ08030 AU23151 AY19074 AU19120 AV12054 AU19119 AV16081 AU16107 AV39134 AT45034 AU01002 AU01026 AV40140 AW35115 AV44161 AV44163 AZ24083 AZ24085 AW06028 AW09032 AW09033 AV21096 AV21093 AV21095 AT49063 AU43240 AW35116 AV14060 AZ06018 AZ17048 AW16056 AV23112 AU43237 AV49190 AU43225 AW09031 AU08041 AZ18054 AV12047 AU13073 AV10038 AY30090 AU43233 AW10039 AW09035 AU08050 AV49184 AU11064 AU14091 AW20066 AU13082 AZ25087 AZ25086 AU28155 AU28157 AU19113 AV01009 AW10042 AW23079 AW49158 AV14070 AW45145 AW16058 AW16059 AY19068 AW28097 AY08030 AU29163 AV36127 AW06030 AW06029 AZ06015 AZ06016 AZ06017 AV40136 AV40137 AU30182 AW06025 AU08047 AU08049 AU43234 AU13079 AY51149 AU23149 AU43223 AU43230 AU43239 AW45140 AU14085 AV12049 AW49164 AW49165…
FDA’s list runs to 3,279 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 to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait, Malaysia, Mayotte, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, and Vietnam.
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.
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 Aug 4, 2016.
- FDA classified it on Aug 30, 2016.
- FDA’s Enforcement Report published it on Sep 7, 2016.
- FDA terminated it on Oct 6, 2016.
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 3,279 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.