The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0156-2020·Announced 2019-10-23

Vital Scientific V-Twin Automated Chemistry Analyzer Recalled for Power Supply Failure

Vital Scientific N.V. is recalling 39 V-Twin automated chemistry analyzers due to a power supply failure that prevents the instruments from producing patient results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 malfunction that prevents the production of patient results, which is a significant functional defect but does not involve direct physical injury or death, fitting the Moderate category for a device malfunction without reported harm.

Plain-English summary

Vital Scientific N.V. is recalling 39 units of the V-Twin automated chemistry analyzer (Catalog # 6002-800, UDI # 03661540600180). The recall was initiated because of a power supply failure. The affected instruments are intended for clinical use.

The recall covers 39 instruments distributed in New York and Utah. Specific serial numbers are listed in the agency's recall notice. The action was taken because during a power supply failure, the instruments malfunction and no patient results are produced.

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

The recalled product

Product
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
Manufacturer
Vital Scientific N.V.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
39

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 (9)

  • serial numbers: 10-3331
  • 10-3332
  • 11-3301
  • 11-3304 through 11-3306
  • 11-3308 through 11-3312
  • 11-3315
  • 11-3316
  • 11-3318 through 11-3342
  • 12-3302.

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 →

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