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

Recall Z-1970-2015 — Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infin

U.S. FDA — Device Enforcement · United States · 2015-05-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1970-2015
Date of alert: 2015-05-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Tecan US, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 30050303

Reported risk: A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

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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