V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
Class I - DangerousWhat Should You Do?
- Check if you have this product: serial numbers: 10-3331; 10-3332; 11-3301; 11-3304 through 11-3306; 11-3308 through 11-3312; 11-3315; 11-3316; 11-3318 through 11-3342; 12-3302.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vital Scientific N.V.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
Product Codes/Lot Numbers:
serial numbers: 10-3331; 10-3332; 11-3301; 11-3304 through 11-3306; 11-3308 through 11-3312; 11-3315; 11-3316; 11-3318 through 11-3342; 12-3302.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0156-2020
Related Recalls
V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Vital Scientific N.V.
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.
Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
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The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Vital Scientific N.V.
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.