UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative,…
Medical device recall Z-2687-2014. Published in FDA’s Enforcement Report on Oct 1, 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 Oct 1, 2014. 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
- 236 units total (70 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 Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.
236 units total (70 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Sample probe cables, Lot number 2014. Serial No. 600785 601704 900359 900950 601257 600968 900613 604013 603950 604006 603963 603972 604002 604008 603995 604004 603939 603940 603932 603934 603978 603998 604009 603948 603945 603977 603956…
Every code shown here, 1,701 characters
Sample probe cables, Lot number 2014. Serial No. 600785 601704 900359 900950 601257 600968 900613 604013 603950 604006 603963 603972 604002 604008 603995 604004 603939 603940 603932 603934 603978 603998 604009 603948 603945 603977 603956 603933 604007 603929 604019 604017 604012 603935 603941 603997 603996 604000 603976 604014 601897 604005 603955 603944 603942 601801 603962 603928 603992 603993 603982 603991 603971 603970 603983 603980 603964 603986 603985 603984 603967 603981 603969 603994 603943 603957 603953 604001 604016 603973 900939 603951 600525 900231 601251 603936 601831 603545 6303547 602589 900913 603859 603860 900368 900935 603078 900782 601493 606694 603693 602113 602595 900933 603917 600571 601220 601265 603013 600794 600306 601718 602771 602782 601925 600758 600857 603007 601658 603717 602020 601894 600891 600882 600980 602036 603539 603706 603975 900940 603999 601510 601381 900947 601624 603946 603949 603947 603952 603016 602996 603974 601509 601513 601928 900834 600931 600693 600511 600341 900264 601969 601109 600113 601791 600959 603931 603966 600680 601305 601872 603503 603125 603915 603988 601255 604003 603965 603989 900851 900826 601984 602278 900765 602356 900581 600343 900948 602313 900057 600912 602360 601828 601745 900722 601764 601210 602533 900566 900539 603879 900928 900927 900949 900212 900065 601724 601827 900796 900951 900946 603694 900941 900930 900929 600233 603938 603954 900936 600657 604015 601567 603147 900944 900938 603765 900632 603968 604010 900937 900636 603752 900531 900429 603930 603937 900932 601967 604011 603979 603987 900931 900710 900934 601622 602561 900426 603961 603959 603958 603960 900592 603473 900943 900952 900945 603865
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.
Nationwide in US and worldwide: Canada, China, Colombia, Croatia, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam.
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 Aug 21, 2014.
- FDA classified it on Sep 23, 2014.
- FDA’s Enforcement Report published it on Oct 1, 2014.
- FDA terminated it on Apr 30, 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.”
- 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.