Z-1520-2018Class III

Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact...

Name: Z-1520-2018 Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact...
Creator: Diagnostic Hybrids, Inc.
Published: 2016-10-26
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-10-26 / Terminated / root cause: manufacturing process

FDA source

Diagnostic Hybrids, Inc. began a recall of Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum on 2016-10-26. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1520-2018
Classification: Class III
Status: Terminated
Initiated: 2016-10-26
Posted: 2018-04-25
Terminated: 2020-08-28
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
Product code: CEW Radioimmunoassay, Parathyroid Hormone
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were notified via letter and email on 10/26/16. Customers were asked to complete and return the attached response form to the recalling firm. Customers were asked to review inventory, quarantine the products with the specified lot numbers, and, if further distributed, identify and notify any additional customers.
Quantity in commerce: 26
Distribution: The product was distributed to the following countries: Singapore, Switzerland
Product codes and lots: Lot 068259

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1520-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1520-2018	Class III	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25

Product code CEW

K974306Class IISangui Biotech, Inc. Intact-Pth (Parathyroid Hormone) ElisaSangui Biotech, Inc. / cleared 1997-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)