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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68090

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

Open FDA event record

Event summary

Timeline bucket
January 10, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Leica Microsystems, 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

Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.

Z-1710-2014
Recall number
Z-1710-2014
Initiated
January 10, 2014
Classification
Class II
Status
Terminated
Recalling firm
Leica Microsystems, Inc.
Quantity
145 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.

Code information

Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03

Distribution pattern

Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom