Reported Oct 1, 2014 · Terminated
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative,…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- 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.
- Lot codes and dates
- Sample probe cables, Lot number 2014. Serial No.
236 of 236 codes
600785601704900359900950601257600968900613604013603950604006603963603972604002604008603995604004603939603940603932603934603978603998604009603948603945603977603956603933604007603929604019604017604012603935603941603997603996604000603976604014601897604005603955603944603942601801603962603928603992603993603982603991603971603970603983603980603964603986603985603984
- Sample probe cables, Lot number 2014. Serial No.
- Amount recalled
- 236 units total (70 units in US)
Where it was sold
- Nationwide
- PR
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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