Device recall

Z-2337-2025: Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog…

FDA device recall · Class II · Mckesson Medical-Surgical Inc. Corporate Office

Key facts

Recall number (Z-number) Z-2337-2025
Recall event 97315
Product Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Product code GTY
Recalling firm Mckesson Medical-Surgical Inc. Corporate Office
Recall class Class II
Status Open, Classified
510(k) numbers K010582
FEI number 3004386693

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)