FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
- Recall number
- Z-1578-2016
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
- Status
- Terminated
- Initiated
- 2016-03-03
- Posted
- 2016-04-27
- Terminated
- 2017-05-25
- Reason
- The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
- Root cause
- Labeling design
- Action
- 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.
- Quantity
- 6,939 pieces
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Material Number - IVD: 5401062001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJH
- Firm FEI
- 2243471
- Firm city
- S Branchburg
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28