FDAClass IIOctober 2, 2019

V-Twin recall: Software Issue

V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type…

Why was V-Twin recalled?

Instrument stopped working due to a software lockup, and no patient results are produced.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial #s: 13-3341 and 13-3344

Product
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type…
Recalling firm
Vital Scientific N.V.
Quantity
2
Distribution
US in the state of New York.
Recall date
October 2, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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