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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77003

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

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Event summary

Timeline bucket
March 13, 2012
Product types
Device
Classifications
Class II
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 Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

Z-2586-2017
Recall number
Z-2586-2017
Initiated
March 13, 2012
Classification
Class II
Status
Terminated
Recalling firm
Medtest Holdings, Inc.
Quantity
270.36 L

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Decrease reactivity of R 1 component.

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

Decrease reactivity of R 1 component.

Code information

Catalog # HB979-693 Lot #'s: 025903-012; 025903-278. Catalog # HB979-711 Lot #'s: 025903-009; 025903-079; 025903-080; 025903-102; 025903-278; 025903-355. Catalog # 7-HB979-R1-40 Lot #: 025903-055. Catalog # 12-HB979-192 Lot #'s: 025903-090; 025903-362.

Distribution pattern

Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE