CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report

MUM-1 (Multiple myeloma oncogene-1) recalled by Biocare Medical

Biocare Medical is recalling MUM-1 (Multiple myeloma oncogene-1), distributed nationwide in the US. The recall was initiated on 12 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.

Quantity recalled59

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0965-2015
FDA event ID: 70010
Recalling firm: Biocare Medical, Concord, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 Dec 2014
FDA classified: 13 Jan 2015
Reported: 21 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

12 Dec 2014	Recall initiated by company
13 Jan 2015	Classified by FDA	+32 days
21 Jan 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arizona California Illinois Louisiana Massachusetts Missouri New York South Carolina Tennessee Texas Washington Wisconsin West Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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