FDA Device recall Z-1520-2018
Quidel MicroVue Intact PTH EIA, Model 8044
- FDA Device
- Class III
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class III recall of Quidel MicroVue Intact PTH EIA, Model 8044 by Diagnostic Hybrids, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1520-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-26 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diagnostic Hybrids |
| Distribution | n/a |
Product
Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Reason
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.
Identifiers
| code_info | Lot 068259 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1520-2018%22
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