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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85660

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

Open FDA event record

Event summary

Timeline bucket
March 20, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Utak Laboratories 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

Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics.

Z-2407-2020
Recall number
Z-2407-2020
Initiated
March 20, 2020
Classification
Class III
Status
Terminated
Recalling firm
Utak Laboratories Inc
Quantity
1,395 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product has an incorrect reference value for cadmium and an incorrect expected range.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product has an incorrect reference value for cadmium and an incorrect expected range.

Code information

Lot C2540

Distribution pattern

Worldwide Distribution. US nationwide, Canada, Australia, France, Germany, Israel, Italy, New Zealand, Philippines, and United Kingdom.