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

Recall Z-0484-2013 — Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Poly

U.S. FDA — Device Enforcement · United States · 2012-07-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0484-2013
Date of alert: 2012-07-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Roche Molecular Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

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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