Device recall

Z-1367-06: AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data…

FDA device recall · Class II · Roche Diagnostics Corp.

Key facts

Recall number (Z-number) Z-1367-06
Recall event 35022
Product AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, contents Accu-Chek Advantage repalcement Meter and module, cat. no. 454; Ref. no. 03144798001 contains meter model no. 777.
Product code CGA
Recalling firm Roche Diagnostics Corp.
Recall class Class II
Status Terminated
Termination date Apr 7, 2008
510(k) numbers K924475
FEI number 1823260

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)