Parvovirus B19 IgG EIA kit Part No. V519IGUS
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 71440040AA
- 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:
- Diasorin Inc.
- Reason for Recall:
- Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Parvovirus B19 IgG EIA kit Part No. V519IGUS
Product Codes/Lot Numbers:
Lot 71440040AA
Distribution:
Distributed in: NJ, WI, NY, NC, MN, CA, IL, VA, MA, MI, CT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2936-2020
Related Recalls
Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result.
DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results.
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.