FDADecember 19, 2024device
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No,...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
What to do
FDA enforcement status: Ongoing
Brands named
ortho clinical diagnosticsorthoortho clinical
UPCs
1075875000274010758750035786
Recall history
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