Device recall

Z-1953-2021: LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004

FDA device recall · Class I · Magellan Diagnostics, Inc.

Key facts

Recall number (Z-number) Z-1953-2021
Recall event 87992
Product LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Product code DOF
Recalling firm Magellan Diagnostics, Inc.
Recall class Class I
Status Terminated
Termination date Oct 24, 2023
510(k) numbers K142705
FEI number 1218996

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)