COULTER LH 750 and LH 780 Analyzers
Medical device recall Z-0113-2014. Published in FDA’s Enforcement Report on Nov 6, 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 6, 2013. 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
- 1,697 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?
The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
1,697 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Numbers: 6605362 for the LH 750 and 723585 for the LH 780. Serial Numbers: AJ08102 AK49053 AM09075 AM10078 AG05059 AK41634 AT02015 AL41189 AJ06078 AF22202 AK34502 AL02001 AS49367 AM10085 AJ10154 AM40321 AS41335 AK32475 AS30241 AU28106…
Every code shown here, 1,993 characters
Part Numbers: 6605362 for the LH 750 and 723585 for the LH 780. Serial Numbers: AJ08102 AK49053 AM09075 AM10078 AG05059 AK41634 AT02015 AL41189 AJ06078 AF22202 AK34502 AL02001 AS49367 AM10085 AJ10154 AM40321 AS41335 AK32475 AS30241 AU28106 AK36538 AL18073 AL18077 AL37150 AH15237 AL09039 AL09042 AK02032 AJ31547 AJ24410 AM24242 AN13074 AN13075 AN13078 AT18112 AT18115 AG45676 AK46036 AG39545 AJ24402 AJ43796 AK49046 AM05019 AH21364 AH21367 AH21368 AH21369 AH21375 AH23391 AT26118 AN11064 AM02006 AE44164 AJ05072 AJ04046 AJ05065 AJ05073 AN19134 AG17221 AH43790 AM20190 AL39172 AT46205 AH43787 AJ04043 AM17139 AM18149 AS35295 AL52333 AF03026 AL50300 AK49040 AL47248 AK11167 AM35324 AS35299 AF44462 AH47839 AJ28468 AG46712 AK46033 AT36156 AT07053 AH38689 AH43782 AG46711 AN19127 AF02009 AJ06081 AJ07089 AE46202 AF06058 AS49369 AG31388 AG48745 AJ08113 AM23218 AG18236 AG21268 AE45183 AL12053 AU10036 AJ23389 AN04028 AN06034 AM40314 AL50405 AK24368 AL52467 AL51444 AG30381 AN25186 AN25187 AM37348 AL46245 AL47251 AG36485 AH29512 AM44418 AM44421 AT02011 AL10069 AN26201 AM04046 AG12158 AV14043 AT38176 AL29255 AG05053 AJ07099 AK21317 AE36072 AS13058 AU51205 AV11032 AK19285 AN39332 AJ29494 AF33293 AN42337 AM35330 AS38206 AL47259 AL29118 AL29119 AM42341 AM22212 AM23230 AM24238 AJ34618 AS23110 AF42431 AF44470 AT35181 AN38312 AN38313 AH36641 AJ45827 AL11095 AJ24440 AL52320 AL52323 AM38275 AM42391 AM42393 RAU51073 AL43212 AG16203 AT49244 AS23098 AL41323 AE29052 AJ28477 AK22335 AL09035 AL49280 AM21202 AN39330 AN04026 AT49245 AJ42784 AM26261 AM26265 AG14178 AG46706 AM19168 AM38283 AN26202 AS36189 AM29276 AM18145 AL43218 AK21322 AG41591 AM33300 AL11093 AK20292 AS46266 AK48746 AS19124 AH11168 AJ33591 AS23097 AL50399 AT08065 AM16138 AM24177 AM29184 AM36269 AL50425 AK11185 AK11189 AJ41760 AN09048 AN13072 AL47268 AN25184 AJ40726 AJ48869 AN49177 AT07060 AS02013 AH15245 AL19085 AL39166 AL39173 AS38205 AH29492 AJ47001 AM38289 AN17106 AJ49883 AM18155 AM43398 AK34498 AK35514 AL37315 AL45366 AM32232…
FDA’s list runs to 13,717 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 - Nationwide Distribution and the country of Canada..
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 Sep 24, 2013.
- FDA classified it on Oct 30, 2013.
- FDA’s Enforcement Report published it on Nov 6, 2013.
- FDA terminated it on Oct 9, 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 13,717 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.