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