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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77083

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

Open FDA event record

Event summary

Timeline bucket
May 15, 2014
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Medtest Holdings, 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

Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.

Z-2121-2017
Recall number
Z-2121-2017
Initiated
May 15, 2014
Classification
Class III
Status
Terminated
Recalling firm
Medtest Holdings, Inc.
Quantity
132919 Vol vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

Code information

Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).

Distribution pattern

Nationwide