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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77276

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

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Event summary

Timeline bucket
September 25, 2016
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Acumedia Manufacturers, 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

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

Z-2221-2017
Recall number
Z-2221-2017
Initiated
September 25, 2016
Classification
Class III
Status
Terminated
Quantity
28 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label was incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.

Code information

PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C

Distribution pattern

Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL