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

Recall Z-1648-2013 — VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrod

U.S. FDA — Device Enforcement · United States · 2013-05-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1648-2013
Date of alert: 2013-05-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ortho-Clinical Diagnostics
Product category: device
Product type: Devices

Reported risk: There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

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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