Reported Sep 10, 2014 · Terminated
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Roche cobas IT 1000 Product UsageIntended
- UseAn electronic device intended to store, retrieve, and process laboratory data
- Lot codes and dates
- Part Numbers
148 of 148 codes
04420306001 Serial #'s: 270627242743274427452749275027512752275427552764277027712772277327742775277627802781278227832784278527892790279127922793279427952796279727982799280828142815281628182819282328242825282628282829283028312847284828492857285828592860286128622863
- Part Numbers
- Amount recalled
- 148 Units
Where it was sold
Why it was recalled
Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that contains a genuine Patient ID (e.g. 999999), which is the same as what has been configured as the Generic Patient ID (999999 by default).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Roche Diagnostics Operations, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.