FDAMay 20, 2020device
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
What to do
FDA enforcement status: Terminated
Brands named
ortho clinical diagnosticsorthoortho clinical
UPCs
10758750002740
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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