FDAJuly 23, 2019device
Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Inaccurately Low Sample Results
What to do
FDA enforcement status: Terminated
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
06779344190
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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