Recall Z-0965-2015
Biocare Medical Llc · initiated December 12, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
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.
FDA-determined cause: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-0965-2015
- Initiated
- December 12, 2014
- Posted by FDA
- January 13, 2015
- Terminated
- March 30, 2015
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- Quantity
- 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.
- Recalling firm
- Biocare Medical Llc, Concord, CA