The Recall Desk
ModerateFDA (Devices)·Z-0154-2020·Announced 2019-10-23

Vital Scientific Viva-JR Automated Chemistry Analyzer Recalled for Power Supply Failure

Vital Scientific N.V. is recalling four Viva-JR automated chemistry analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a power supply failure that causes the device to malfunction and fail to produce patient results, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Vital Scientific N.V. is recalling four units of the Viva-JR automated chemistry analyzer (catalog # 6002-940, UDI # 03661540600210). The affected units have serial numbers 11-1302, 11-303, 11-304, and 11-1305. These devices are intended for clinical use.

The recall was initiated because of a power supply failure. When this failure occurs, the instruments malfunction and no patient results are produced. The affected units were distributed nationwide in the states of New York and Utah.

Healthcare facilities and consumers should stop using the affected units and contact Vital Scientific N.V. for further instructions on the recall.

The recalled product

Product
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • serial numbers: 11-1302
  • 11-303
  • 11-304
  • 11-1305

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Vital Scientific N.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →