Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
- 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:
- Clark Laboratories, Inc.
- Reason for Recall:
- Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
Product Codes/Lot Numbers:
Lot # 056 Expiration Date: 2022-11-28 UDI: 05391516744065
Distribution:
Distributed in: OH, UT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0382-2022
Related Recalls
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting