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
103800621038006110380079103800651036021010283632
- IMMULITE 2000XPi
P010053/S00710373214
- VersaCell
1038006310389945103800641028711510793839
- IMMULITE 2000
- 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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