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

Recall Z-1664-2023 — VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and t

U.S. FDA — Device Enforcement · United States · 2023-04-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1664-2023
Date of alert: 2023-04-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ortho-Clinical Diagnostics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10758750006601

Reported risk: Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing

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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