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Terminated

Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

FDA Recall Z-0155-2020 · Posted None

Recalling FirmVital Scientific N.V.
Recall StatusTerminated
Product CodeJJF
Date Initiated2012-01-10
Date Terminated2024-04-19
Product Quantity75 units

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.

K973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVAVital Scientific N.V. · 1998-03-13

Official Source

View FDA Recall →

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

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