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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76619

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 15, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Focus Diagnostics 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

2 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 2

Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

Z-1685-2017
Recall number
Z-1685-2017
Initiated
February 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Focus Diagnostics Inc
Quantity
196 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.

Code information

Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850

Distribution pattern

Product was distributed to three testing laboratories in California, New Jersey and Virginia

device · product 2 of 2

Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

Z-1686-2017
Recall number
Z-1686-2017
Initiated
February 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Focus Diagnostics Inc
Quantity
1,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.

Code information

IF0951: 10816101020055, lot numbers 29428, 31871

Distribution pattern

Product was distributed to three testing laboratories in California, New Jersey and Virginia