Diagnostic Hybrids, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1520-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: October 26, 2016

Date Posted: May 2, 2018

Recall Number: Z-1520-2018

Event ID: 79595

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.

Status: Terminated

Product Quantity: 26

Code Information:

Lot 068259

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated