Recall
MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN MagNA Pure LC 2.0 instrument is a robotic instrument for automated isolation of nucleic acids (DNA, total RNA , total viral nucleic acids)…
Roche Diagnostics Operations, Inc. · 26 Oct 2010
- Status
- Recall terminated
- Why, in the FDA's words
- “If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the MPLC 2.0 software. This may result in sample mis identification. If printed from the ordering screens, the bar code is printed with the correct batch ID.”
- Recall began
- 26 Oct 2010
- Company
- Roche Diagnostics Operations, Inc.
- Device type
- Product code (OOI)
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.