Device recall

Z-0220-2009: Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc…

FDA device recall · Class II · Pointe Scientific, Inc.

Key facts

Recall number (Z-number) Z-0220-2009
Recall event 49466
Product Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)
Product code CFR
Recalling firm Pointe Scientific, Inc.
Recall class Class II
Status Terminated
Termination date Nov 27, 2009
510(k) numbers K002199
FEI number 1827821

At a glance

  • 1–9 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

Browse all FDA device recalls (products)