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

Recall Z-0220-2023 — VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Syste

U.S. FDA — Device Enforcement · United States · 2022-10-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0220-2023
Date of alert: 2022-10-13
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): 10758750005031

Reported risk: Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.

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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