Vital Scientific Selectra ProS Analyzer Recalled for Power Supply Failure
Vital Scientific is recalling six Selectra ProS Analyzers due to power supply failures that cause instrument malfunction and prevent the production of 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 instrument malfunction leading to a lack of patient results, which is a significant operational risk but does not involve direct physical injury or death, fitting the Moderate criteria for a Class II recall without reported hospitalizations.
Plain-English summary
Vital Scientific N.V. is recalling six units of the Selectra ProS Analyzer, a clinical chemistry system intended for use in clinical laboratories. 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 instruments are distributed in New York and Utah. The specific serial numbers for the recalled units are 11-9609, 11-9690, 11-9694, 11-9695, 12-9618, and 12-9620. The product is identified by Catalog # 6003-600 and UDI # 03661540600418.
Clinical laboratories should check their inventory for these specific serial numbers. If a unit is affected, it should be removed from service to prevent the production of invalid patient results due to instrument malfunction.
The recalled product
- Product
- Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
- Manufacturer
- Vital Scientific N.V.
- Affected units
- 6
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 (6)
- serial numbers: 11-9609
- 11-9690
- 11-9694
- 11-9695
- 12-9618
- 12-9620.
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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