Device recall

Z-0465-2015: Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per…

FDA device recall · Class II · Remel Inc

Key facts

Recall number (Z-number) Z-0465-2015
Recall event 69566
Product Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella…
Product code LIB
Recalling firm Remel Inc
Recall class Class II
Status Terminated
Termination date Jan 22, 2015
FEI number 1924669

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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