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Terminated

Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

FDA Recall Z-0158-2020 · Posted None

Recalling FirmVital Scientific N.V.
Recall StatusTerminated
Product CodeJGS
Date Initiated2012-01-10
Date Terminated2024-04-19
Product Quantity6 instruments

Reason for Recall

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Firm Action

The firm reached out to consignees via phone to inform them of the affected product.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide in the states of NY, and UT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102647ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...Elitechgroup Vital Scientific BV · 2011-03-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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