V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Class I - DangerousWhat Should You Do?
- Check if you have this product: The following serial numbers: 14-3301-14-3344; 15-3301-15-3326; 16-3301 -16-3353; 17-3301 -17-3346; 18-3301-18-3323
- 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 is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.
- 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: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
Product Codes/Lot Numbers:
The following serial numbers: 14-3301-14-3344; 15-3301-15-3326; 16-3301 -16-3353; 17-3301 -17-3346; 18-3301-18-3323
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0038-2020
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
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.
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.