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

Recall Z-0077-2015 — VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric en

U.S. FDA — Device Enforcement · United States · 2014-09-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0077-2015
Date of alert: 2014-09-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ortho-Clinical Diagnostics
Product category: device
Product type: Devices

Reported risk: Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).

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.

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