Reported May 4, 2016 · Terminated
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Roche Molecular Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733
Is this the product you have?
- Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
- Lot codes and dates
- Material Number - IVD5401062001
- Amount recalled
- 6,939 pieces
Where it was sold
- Nationwide
Why it was recalled
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
This product could cause temporary or reversible health problems — stop using it.
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