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

Recall Z-0237-2018 — UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)

U.S. FDA — Device Enforcement · United States · 2017-11-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0237-2018
Date of alert: 2017-11-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter Inc.
Product category: device
Product type: Devices

Reported risk: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

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.

Recall Z-0237-2018 — UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)

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