Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70010

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

Open FDA event record

Event summary

Timeline bucket
December 12, 2014
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

MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.

Z-0965-2015
Recall number
Z-0965-2015
Initiated
December 12, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biocare Medical Llc
Quantity
59

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.

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

Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.

Code information

Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.

Distribution pattern

Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.