ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated…
Medical device recall Z-0152-2014. 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 for where it went
- 4584 units total (1173 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?
The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
4584 units total (1173 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
AU400, Item Code: 5427200 5427400 5427600 N1254000 N1254200 N1254400 N1254600 N1255000 n1255200 N1257400 N2571700 N2571800 N3658500 N3658700 N3658800 N3659000 N3659400 N3912300 N9020723 N9020724 AU400 OPA, Item Code: 5427300 5427900…
Every code shown here, 959 characters
AU400, Item Code: 5427200 5427400 5427600 N1254000 N1254200 N1254400 N1254600 N1255000 n1255200 N1257400 N2571700 N2571800 N3658500 N3658700 N3658800 N3659000 N3659400 N3912300 N9020723 N9020724 AU400 OPA, Item Code: 5427300 5427900 N1257700 AU640, Item Code: 5900100 5900400 5900600 N1255700 N1255900 N1256100 N1256300 N1256700 N2572800 N3660900 N3661200 N3661300 N3661500 N3661700 N3661900 AU640 OPA, Item Code: 590220 5902400 A92928 A92929 AU2700, Item Code: 5996300 5996500 5998100 N1465100 N1465300 N1465500 N1465600 N1465900 N1466100 N1815200 N1815600 N1815700 N1816200 N1816300 N3155800 N3155900 N3156000 N3156100 N3156200 N3156300 N3156400 N3156500 N3156600 N3156800 N3157000 N3663100 N3663300 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 AU2700 OPA, Item Code: 5996100 N3156700 N9025844 AU5400 OPA, Item Code: 6196400 6196500 6196700 N1257900 N1258000 N3666000 N3877100 N3877200 N3877300 N3877600 N3877700
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-USA (nationwide) and the countries of Canada, Vietnam, Zambia, and Zimbabwe.
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 9, 2013.
- FDA classified it on Nov 5, 2013.
- FDA’s Enforcement Report published it on Nov 13, 2013.
- FDA terminated it on Sep 30, 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.”
- 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.