Hand-Held Scanner USB IT3800 For sample identification recall
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Why was Hand-Held Scanner USB IT3800 For sample identification recalled?
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material Number - IVD: 5401062001
- Product
- Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 6,939 pieces
- Distribution
- Nationwide Distribution
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)