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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64164

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 23, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Bion Enterprises Ltd

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

3 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 3

Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Z-1477-2013
Recall number
Z-1477-2013
Initiated
January 23, 2013
Classification
Class III
Status
Terminated
Recalling firm
Bion Enterprises Ltd
Quantity
207 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected products have a labeled expiration date of one year too long.

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

Affected products have a labeled expiration date of one year too long.

Code information

Product Code: CCG-9912; Lot: CCG-0280

Distribution pattern

Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)

device · product 2 of 3

Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Z-1478-2013
Recall number
Z-1478-2013
Initiated
January 23, 2013
Classification
Class III
Status
Terminated
Recalling firm
Bion Enterprises Ltd
Quantity
201 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected products have a labeled expiration date of one year too long.

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

Affected products have a labeled expiration date of one year too long.

Code information

Product Code: CCM-9914; Lot: CCM-0281

Distribution pattern

Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)

device · product 3 of 3

Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Z-1479-2013
Recall number
Z-1479-2013
Initiated
January 23, 2013
Classification
Class III
Status
Terminated
Recalling firm
Bion Enterprises Ltd
Quantity
504 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected products have a labeled expiration date of one year too long.

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

Affected products have a labeled expiration date of one year too long.

Code information

Product Code: CCG-9972; Lot: CCG-0281

Distribution pattern

Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro)