Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot 068259
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Diagnostic Hybrids, Inc.
Reason for Recall:
There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

Product Codes/Lot Numbers:

Lot 068259

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1520-2018

Related Recalls

There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.

Apr 4, 2017 Other Medical Devices View Details →