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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Beckman Coulter Inc.
- Reason for Recall:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2687-2014
Related Recalls
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Beckman Coulter
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.