Recall
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic…
Siemens Medical Solutions Diagnostics · 3 Feb 2014
- Status
- Recall terminated
- Why, in the FDA's words
- “There is a potential for incorrect results to be reported from processing of a sample tube.”
- Recall began
- 3 Feb 2014
- Company
- Siemens Medical Solutions Diagnostics
- Device type
- Product code (JJE)
- Concerns
- K970227
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.