Reported Apr 9, 2014 · Terminated

IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that…

Siemens Medical Solutions Diagnostics

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: Siemens Medical Solutions Diagnostics · 62 Flanders-Bartley Rd · Flanders, NJ · 07836-4715

Is this the product you have?

  • 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 testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Lot codes and dates
  • IMMULITE 2000
    • 10380062
    • 10380061
    • 10380079
    • 10380065
    • 10360210
    • 10283632
  • IMMULITE 2000XPi
    • P010053/S007
    • 10373214
  • VersaCell
    • 10380063
    • 10389945
    • 10380064
    • 10287115
    • 10793839
Amount recalled
1006 units

Where it was sold

  • Nationwide

Why it was recalled

There is a potential for incorrect results to be reported from processing of a sample tube.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 30, 2016 · Data as of Sep 19, 4:48 PM UTC

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