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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62987

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

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Event summary

Timeline bucket
August 20, 2012
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Microgenics Corporation

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

Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .

Z-0379-2013
Recall number
Z-0379-2013
Initiated
August 20, 2012
Classification
Class III
Status
Terminated
Recalling firm
Microgenics Corporation
Quantity
2076 total in US , 596 total Foreign

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.

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

In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.

Code information

MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014. MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.

Distribution pattern

Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.

Field note

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