Device recall

Z-1354-06: ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat…

FDA device recall · Class II · Roche Diagnostics Corp.

Key facts

Recall number (Z-number) Z-1354-06
Recall event 35022
Product ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Ref. no. 080087000 with meter model number 870; Ref. no.0353756001 with meter model number 33304510; Ref. no. 03537536001 with meter model no. 2138930; Ref. no. 03537536001 with meter model no. 3288650.
Product code CGA
Recalling firm Roche Diagnostics Corp.
Recall class Class II
Status Terminated
Termination date Apr 7, 2008
510(k) numbers K930979
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)