Quidel MicroVue Intact PTH EIA — Class III medical device recall Z-1520-2018
Terminated recall by Diagnostic Hybrids, Inc., reported 2018-05-02. There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lo
| Recall number | Z-1520-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostic Hybrids, Inc., Athens, OH, United States |
| Recall initiated | 2016-10-26 |
| Classified | 2018-04-25 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-08-28 |
| Countries outside the US | CH, SG |
| Quantity | 26 |
| Reason classes | potency |
| Lot numbers | 068259 |
| Model numbers | 8044 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1520-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.