Device recall

Z-0965-2015: MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage…

FDA device recall · Class II · Biocare Medical Llc

Key facts

Recall number (Z-number) Z-0965-2015
Recall event 70010
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…
Product code NJT
Recalling firm Biocare Medical Llc
Recall class Class II
Status Terminated
Termination date Mar 30, 2015
FEI number 3004140393

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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