FDA Device recall Z-1578-2016
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems by Roche Molecular Systems, citing the hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1578-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-03 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Reason
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Identifiers
| code_info | Material Number - IVD: 5401062001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1578-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.