Device recall

Z-2460-2026: directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number…

FDA device recall · Class II · Accriva Diagnostics, Inc.

Key facts

Recall number (Z-number) Z-2460-2026
Recall event 98979
Product directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Product code GGN
Recalling firm Accriva Diagnostics, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K202101
FEI number 2250033

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)