UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic… — Class II medical device recall Z-2687-2014
Terminated recall by Beckman Coulter Inc., reported 2014-10-01, distributed nationwide. Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been install
| Recall number | Z-2687-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2014-08-21 |
| Classified | 2014-09-23 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, CN, CO, CZ, DE, ES, FR, GB, HR, IN, IT, JP, KR, KW, MX, MY, PH, RU, SE, SG, SK, TH, TR, TW, VN, ZA |
| Lot numbers | 2014 |
| Serial numbers | 600113, 600233, 600306, 600341, 600343, 600511, 600525, 600571, 600657, 600680, 600693, 600758, 600785, 600794, 600857, 600882, 600891, 600912, 600931, 600959, 600968, 600980, 601109, 601210, 601220 and 211 more |
Product
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.
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.