FDA-Device2015-11-25Class II
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Roche Diagnostics Operations, Inc.
Hazard
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Sold states
Distributed to TX only.
Affected count
1
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0297-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief