RecallDepth

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

Company
Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands
Recall Initiated
January 10, 2012
Terminated
April 19, 2024
Recall Number
Z-0155-2020
Quantity
75 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.

Distribution

US Nationwide in the states of NY, and UT

Lot / Code Info

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.

Root Cause

Component design/selection

Action Taken

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

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