FDA recall Z-0547-2020

Product

V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

Reason for recall

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.

Distribution

NY

Key facts

Status

Ongoing

Initiation date

2018-11-15

Report date

2019-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dieren, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0547-2020