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

Recall Z-1217-2017 — The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.

U.S. FDA — Device Enforcement · United States · 2016-05-05 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1217-2017
Date of alert: 2016-05-05
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices

Reported risk: Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

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.

Recall Z-1217-2017 — The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.

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