Device recall

Z-0179-2015: Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a…

FDA device recall · Class II · Leica Microsystems, Inc.

Key facts

Recall number (Z-number) Z-0179-2015
Recall event 68079
Product Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4)…
Product code NJT
Recalling firm Leica Microsystems, Inc.
Recall class Class II
Status Terminated
Termination date Aug 14, 2017
FEI number 3000210133

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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