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

Recall Z-2241-2021 — Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational Lice

U.S. FDA — Device Enforcement · United States · 2021-06-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2241-2021
Date of alert: 2021-06-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Beckman Coulter, Inc.
Product category: device
Product type: Devices

Reported risk: Software anomalies that may lead to the generation of erroneous results.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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