VITROS XT 7600 Integrated System recall
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The…
Why was VITROS XT 7600 Integrated System recalled?
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number 76000108 thru current.
- Product
- VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 85 units: US=19;OUS=66
- Distribution
- Worldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines
- Recall date
- May 29, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)