V-Twin recall
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Why was V-Twin recalled?
During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
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?
(OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345; (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037
- Product
- V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
- Recalling firm
- Vital Scientific N.V.
- Quantity
- 732 instruments
- Distribution
- NY
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)