UniCel DxC 600i SYNCHRON Access Clinical Analyzer
Medical device recall Z-0176-2015. Published in FDA’s Enforcement Report on Nov 12, 2014.
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 12, 2014. 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
- 1,519 units total (403 units total) 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 Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a “MFC Exception” error during normal operation of the analyzer system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
1,519 units total (403 units total), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626…
Every code shown here, 1,995 characters
Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626 509797 509669 509765 509790 509798 509739 509736 509769 509287 504104 509063 509256 509511 503600 505722 502105 504597 503503 504557 505476 504095 504060 503183 505154 506131 509267 509524 500646 509532 501760 509369 509514 509177 800135 509313 504619 800074 504591, 508910, 508912, 508907 509373, 509304 506566 508920 505811 508914, 508917 509625 502796 508933, 508934 509291 509634, 509635 509530, 509588 509787, 509788, 509783 509433, 509437, 509662, 509663, 509660, 509659, 509658 509715 509657 508916, 508566, 509344, 509526, 509424, 509461, 509459, 509466, 509062, 509197, 509200, 509195, 509196, 509201, 509199, 509605, 509604, 509571, 509585, 509567, 509569, 509568, 509566, 509579, 509570 508887, 509489, 509542, 509538, 509541, 509645, 509647, 509652, 509649, 509648, 509642, 509644 509341, 509346 508885, 508891, 509781, 509782, 509770 509026, 509020, 509025, 509027, 509028, 509021 509651, 509784 509194, 509190 509713, 509710 509175 509560, 509557, 509556, 509558 509553, 509554 509219, 509237, 509236, 509233, 509231, 509234, 509238, 509212, 509240, 509230, 509208, 509216, 509232, 509214 509535 509072, 508994, 508981, 508990 509531, 509417, 509398, 509759 509089 509050, 508991 508884, 508888, 508870, 509075, 509074, 509076, 509069, 509147, 509145, 509155 509442, 509443 509622 509107 508937, 509697, 509698 509821, 509810 509512, 509169, 509174, 509170, 509695 509610, 509620, 509613 509355, 509471, 509468, 509699, 509700, 509702, 509703 509517, 509520, 509664, 509665, 509666 509637 508954, 508996, 509203, 509210, 509205, 509209 509401, 509202, 509780, 509779 509423 ,509426, 509806, 509804, 509812, 509807, 509805 509561 508940 509564 509141 509142 509156 509507 509598 509023 509045 509090 509342 509217 509098 509104 509359 509415…
FDA’s list runs to 10,986 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 in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Germany, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States including Puerto Rico, Venezuela, 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 Oct 6, 2014.
- FDA classified it on Nov 5, 2014.
- FDA’s Enforcement Report published it on Nov 12, 2014.
- FDA terminated it on Jun 29, 2015.
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 10,986 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.