Exact FDA event identifier

Event 79595

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: October 26, 2016
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Diagnostic Hybrids, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1520-2018

Recall number: Z-1520-2018
Initiated: October 26, 2016
Classification: Class III
Status: Terminated
Recalling firm: Diagnostic Hybrids, Inc.
Quantity: 26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot 068259

Distribution pattern

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