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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70823

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

Open FDA event record

Event summary

Timeline bucket
March 17, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biocare Medical, LLC

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

CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.

Z-1535-2015
Recall number
Z-1535-2015
Initiated
March 17, 2015
Classification
Class II
Status
Terminated
Recalling firm
Biocare Medical, LLC
Quantity
44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.

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

A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.

Code information

Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.

Distribution pattern

Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.

Field note

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