Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
FDA device recall Z-1578-2016 · posted 2016-04-27 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- Reason for recall
- The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
- Action taken
- Roche Molecular Systems sent an "Urgent Medical Device Correction (UMDC) notification letter dated March 3, 2016, to their affected customers. Customers were instructed to provide the UMDC to other affected parties who may need to be aware of this issue. Customers were asked to complete the attached fax form and fax it to 1-866-737-5396. Customers with questions should contact Roche Support Network Customer Support Center at 1-800-526-1247. For questions regarding this recall call 908-253-7200.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JJH
- Quantity affected
- 6,939 pieces
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-03-03
- Date posted
- 2016-04-27
- Date terminated
- 2017-05-25
- Location
- S Branchburg, NJ
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