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

Recall Z-1736-2014 — VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.

U.S. FDA — Device Enforcement · United States · 2014-04-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1736-2014
Date of alert
2014-04-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
34000337
Reported risk: Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected
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.

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