FDADecember 21, 2022device
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
What to do
FDA enforcement status: Ongoing
Brands named
roche molecular systemsrocheroche molecular
UPCs
0087519700677309233962190
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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