FDA-Device2012-12-19Class II
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Roche Molecular Systems, Inc.
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Sold states
Nationwide Distribution
Affected count
1,015 units
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0491-2013Don'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