Device recall

Z-0104-2010: Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc…

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

Key facts

Recall number (Z-number) Z-0104-2010
Recall event 53583
Product Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) Pointe Scientific Liquid Glucose (HEXO) is used for the…
Product code CFR
Recalling firm Pointe Scientific, Inc.
Recall class Class I
Status Terminated
Termination date Sep 27, 2010
510(k) numbers K971754
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)