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

Recall Z-1936-2019 — VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layere

U.S. FDA — Device Enforcement · United States · 2019-04-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1936-2019
Date of alert: 2019-04-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ortho-Clinical Diagnostics
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10758750002054

Reported risk: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

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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