Vital Scientific Viva-E Automated Chemistry Analyzer Recalled for Power Supply Failure
Vital Scientific N.V. is recalling 75 Viva-E automated chemistry analyzers due to power supply failures that prevent the instruments from producing 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 is a functional failure that prevents the production of 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 75 units of the Viva-E automated chemistry analyzer (Catalog # 6002-380, UDI # 03661540600050). The recall was initiated because of a power supply failure that causes the instruments to malfunction and fail to produce patient results.
The affected units were distributed nationwide in New York and Utah. Specific serial numbers are listed in the agency's recall record. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities should stop using the affected units and contact Vital Scientific N.V. for instructions on how to proceed with the recall.
The recalled product
- Product
- Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
- Manufacturer
- Vital Scientific N.V.
- Affected units
- 75
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 (13)
- serial numbers: 10-4582 till 10-4584
- 10-4586 till 10-4594
- 11-2309
- 11-2320 t through 11-2328
- 11-2330 through-2334
- 11-2336 through 11-2375
- 11-2383
- 11-2384
- 11-2388
- 11-2395
- 12-2314
- 12-2315
- 12-2324 12-2325.
Distribution
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.
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