Home / Recalls / Vital Scientific N.V. / Z-0547-2020

Z-0547-2020 Class II Ongoing

Recalled by Vital Scientific N.V. — Dieren

Recall Details

Product Type
Devices
Report Date
December 4, 2019
Initiation Date
November 15, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
732 instruments

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.

Distribution Pattern

NY

Code Information

(OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345; (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037

Other recalls by Vital Scientific N.V.

  • Z-0038-2020 Class II — V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro dia (September 7, 2018)
  • Z-2558-2019 Class II — V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro dia (January 18, 2016)
  • Z-0154-2020 Class II — Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automa (January 10, 2012)
  • Z-0157-2020 Class II — Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 60 (January 10, 2012)
  • Z-0155-2020 Class II — Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated c (January 10, 2012)
  • Z-0156-2020 Class II — V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated c (January 10, 2012)
  • Z-0158-2020 Class II — Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage (January 10, 2012)