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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79621

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

Open FDA event record

Event summary

Timeline bucket
July 14, 2016
Product types
Device
Classifications
Class II
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

MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

Z-1797-2018
Recall number
Z-1797-2018
Initiated
July 14, 2016
Classification
Class II
Status
Terminated
Recalling firm
Diagnostic Hybrids, Inc.
Quantity
1004

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility of low volume and/or leaking standard bottles.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possibility of low volume and/or leaking standard bottles.

Code information

Lot 067850

Distribution pattern

The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.