MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody

FDA device recall Z-0965-2015 · posted 2015-01-13 · Terminated

Recall details

Recalling firm

Biocare Medical Llc

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.

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

NJT

Quantity affected

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.

Date initiated

2014-12-12

Date posted

2015-01-13

Date terminated

2015-03-30

Location

Concord, CA