Hand-Held Scanner USB IT3800 For sample identification and tracking… — Class II medical device recall Z-1578-2016
Terminated recall by Roche Molecular Systems, Inc., reported 2016-05-04, distributed nationwide. The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample ba
| Recall number | Z-1578-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2016-03-03 |
| Classified | 2016-04-27 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2017-05-25 |
| Distributed | Nationwide (US) |
| Quantity | 6,939 units |
Product
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Reason for recall
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.