# FDA recall Z-1520-2018

> **Diagnostic Hybrids, Inc.** · Class III · device recall initiated 2016-10-26.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1520-2018
- **Recalling firm:** Diagnostic Hybrids, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-10-26
- **Report date:** 2018-05-02
- **Termination date:** 2020-08-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2018

## Citation

> AI Analytics. FDA recall Z-1520-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1520-2018. Source: US FDA. Licensed CC0.

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