Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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 /A64

U.S. FDA — Device Enforcement · United States · 2018-12-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1078-2019
Date of alert: 2018-12-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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