FDAMarch 3, 2016device

Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.

What to do

FDA enforcement status: Terminated

Brands named

roche molecular systemsrocheroche molecular

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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