Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Quidel MicroVue Intact PTH EIA Recalled by Diagnostic Hybrids, Inc. Due to There may be a loss of separation between...

Date: October 26, 2016
Company: Diagnostic Hybrids, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostic Hybrids, Inc. directly.

Affected Products

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

Quantity: 26

Why Was This Recalled?

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.

Where Was This Sold?

The product was distributed to the following countries: Singapore, Switzerland

About Diagnostic Hybrids, Inc.

Diagnostic Hybrids, Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report