Reported May 29, 2019 · Terminated
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro…
Ortho-Clinical 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: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
VITROS XT 7600 Integrated Systemwith V3.4 or 3.4.1
- SW Product Code6844461
- Product UsageINTENDED
- USEFor in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
- Lot codes and dates
- Serial Number 76000108 thru current.
- Amount recalled
- 85 units: US=19;OUS=66
Where it was sold
Why it was recalled
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
This product could cause temporary or reversible health problems — stop using it.
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