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

Recall Z-2276-2021 — Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

U.S. FDA — Device Enforcement · United States · 2021-07-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2276-2021
Date of alert: 2021-07-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Laboratories, Inc
Product category: device
Product type: Devices

Reported risk: A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

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-2276-2021 — Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

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