FDA-Device2019-12-04Class II
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Vital Scientific N.V.
Hazard
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
Sold states
NY
Affected count
732 instruments
Manufactured in
24, Kanaalweg, Postbus 100, Dieren, Netherlands
Products
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0547-2020Don't want to check this manually?
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