AUTION HYBRID AU-4050
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: (01) 00015482146030 All serial numbers
- 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:
- Arkray Factory USA, Inc.
- Reason for Recall:
- This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AUTION HYBRID AU-4050
Product Codes/Lot Numbers:
UDI: (01) 00015482146030 All serial numbers
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1850-2019
Related Recalls
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.