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

Recall Z-2035-2017 — AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection

U.S. FDA — Device Enforcement · United States · 2017-04-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2035-2017
Date of alert: 2017-04-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter Inc.
Product category: device
Product type: Devices

Reported risk: Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.

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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