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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70767

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

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Event summary

Timeline bucket
March 04, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hardy Diagnostics

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

Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.

Z-1444-2015
Recall number
Z-1444-2015
Initiated
March 04, 2015
Classification
Class II
Status
Terminated
Recalling firm
Hardy Diagnostics
Quantity
840 (84 pk/10)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.

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

The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.

Code information

Lot no. 15037, Expires: 00-00-2000

Distribution pattern

Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.