FDA Device recall Z-1078-2019
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the…
- FDA Device
- Class II
- ongoing
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class II recall of UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the… by Beckman Coulter, citing when racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1078-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-05 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | AK, AL, CA, DC, FL, GA, ID, IL, IN, KY, LA, MA, MI, MN, MS, NC, ND, NJ, NY, OH, PA, TN, TX, WA, WI, WV |
Product
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102
Reason
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
Identifiers
| code_info | Systems running software versions: 5.2, 5.3.0, 5.3.1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1078-2019%22
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