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Vital Scientific N.V. recalls V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Recalled December 4, 2019 · FDA recall Z-0547-2020 · 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. · FDA Class II
Units
732 instruments
Sold at
NY
Description
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.
Product
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Manufacturer(s)
Vital Scientific N.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →