Z-1578-2016Class II

Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems

Name: Z-1578-2016 Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Creator: Roche Molecular Systems, Inc.
Published: 2016-03-03
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2016-03-03 / Terminated / root cause: labeling and UDI

FDA source

Roche Molecular Systems, Inc. began a recall of Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems on 2016-03-03. FDA classified it as Class II and gives the reason as "The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1578-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-03
Posted: 2016-04-27
Terminated: 2017-05-25
Recalling firm: Roche Molecular Systems Inc
Product: Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Product code: JJH Clinical Sample Concentrator
Reason for recall: The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Root cause tag: labeling and UDI
FDA 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 in commerce: 6,939 pieces
Distribution: Nationwide Distribution
Product codes and lots: Material Number - IVD: 5401062001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1578-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1578-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)