Recall Z-0547-2020— Vital Scientific N.V.

Name: FDA recall Z-0547-2020
Creator: U.S. Food and Drug Administration
Published: 2018-11-15

Class II · Ongoing

Class II FDA medical device recall by Vital Scientific N.V., initiated 2018-11-15. It names one FDA 510(k) clearance: K973628. Product: V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180. Reason: 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..

Recalling firm: Vital Scientific N.V.
Classification: Class II
Status: Ongoing
Initiated: 2018-11-15
Firm location: Dieren, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVAVital Scientific N.V.·cleared 1998-03-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.