Vital Scientific Selectra ProM Analyzer Recalled for Power Supply Failure
Vital Scientific N.V. is recalling five Selectra ProM Analyzers due to power supply failures that cause instrument malfunction and prevent the production of patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a malfunction prevents the production of patient results, representing a risk of harm to patients due to lack of diagnostic data, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Vital Scientific N.V. is recalling five units of the Selectra ProM Analyzer, a clinical chemistry system intended for use in clinical laboratories. The affected instruments are identified by Catalog # 6003-435 (UDI # 03661540600395) and Catalog # 6003-436 (UDI # 03661540600401). The specific serial numbers for the recalled units are 11-7425, 11-7516, 11-7535, 11-7563, and 11-7564.
The recall was initiated because of a power supply failure. When this failure occurs, the instruments malfunction and no patient results are produced. This issue affects the reliability of the clinical chemistry system in generating necessary diagnostic data.
The affected instruments were distributed in the United States, specifically in the states of New York and Utah. Clinical laboratories should check their inventory for these specific serial numbers and contact Vital Scientific N.V. for further instructions on the recall.
The recalled product
- Product
- Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
- Manufacturer
- Vital Scientific N.V.
- Affected units
- 5
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 (5)
- serial numbers: 11-7425
- 11-7516
- 11-7535
- 11-7563
- 11-7564.
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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