Device recall

Z-0038-2020: V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro…

FDA device recall · Class II · Vital Scientific N.V.

Key facts

Recall number (Z-number) Z-0038-2020
Recall event 83648
Product V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry…
Product code JJF
Recalling firm Vital Scientific N.V.
Recall class Class II
Status Terminated
Termination date Jun 29, 2022
510(k) numbers K973628
FEI number 3001576181

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)