Device recall

Z-1312-2024: Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson…

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

Key facts

Recall number (Z-number) Z-1312-2024
Recall event 94024
Product Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Product code JJX
Recalling firm Mckesson Medical-Surgical Inc. Corporate Office
Recall class Class II
Status Open, Classified
510(k) numbers K050328
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)