Exact FDA event identifier

Event 67065

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

Open FDA event record

Event summary

Timeline bucket: December 06, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Lab Vision Corporation

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

Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.

Z-0775-2014

Recall number: Z-0775-2014
Initiated: December 06, 2013
Classification: Class II
Status: Terminated
Recalling firm: Lab Vision Corporation
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.

Code information

PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.

Distribution pattern

Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.