Z-0965-2015Class II

MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA

Name: Z-0965-2015 MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA
Creator: Biocare Medical Llc
Published: 2014-12-12
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2014-12-12 / Terminated / root cause: labeling and UDI

FDA source

Biocare Medical Llc began a recall of 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... on 2014-12-12. FDA classified it as Class II and gives the reason as "Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0965-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-12
Posted: 2015-01-13
Terminated: 2015-03-30
Recalling firm: Biocare Medical LLC
Product: 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.
Product code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Biocare sent a Medical Device Recall notifications letter to all customers by traceable method. The letters identified the affected product, problem and actions to be taken. Users are asked to immediately discontinue used of the affected lots and dispose of them according to applicable national, state and local laws. Users are requested to complete and return the response form so that proper credit can be issues 800-799-9499.
Quantity in commerce: 59
Distribution: 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.
Product codes and lots: Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0965-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0965-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-13

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)