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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68583

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

Open FDA event record

Event summary

Timeline bucket
June 11, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Remel 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

Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.

Z-2057-2014
Recall number
Z-2057-2014
Initiated
June 11, 2014
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
76/50-bottle boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.

Code information

Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10

Distribution pattern

Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.