| Date Initiated by Firm | January 10, 2012 |
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| Create Date | October 16, 2019 |
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| Recall Status1 |
Terminated 3 on April 19, 2024 |
| Recall Number | Z-0155-2020 |
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| Recall Event ID |
83582 |
| 510(K)Number | K973628 |
|---|
| Product Classification |
Analyzer, chemistry, micro, for clinical use - Product Code JJF
|
| Product | Viva-E, Catalog # 6002-380, UDI # 03661540600050
Product Usage: automated chemistry analyzer intended for clinical use |
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| Code Information |
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. |
Recalling Firm/
Manufacturer |
Vital Scientific N.V.
24, Kanaalweg
Postbus 100
Dieren Netherlands
|
Manufacturer 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. |
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FDA Determined
Cause 2 | Component design/selection |
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| Action | The firm reached out to consignees via phone to inform them of the affected product. |
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| Quantity in Commerce | 75 units |
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| Distribution | US Nationwide in the states of NY, and UT |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = JJF
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