Device recall

Z-1970-2023: SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample…

FDA device recall · Class II · LumiraDx

Key facts

Recall number (Z-number) Z-1970-2023
Recall event 92334
Product SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Product code KXG
Recalling firm LumiraDx
Recall class Class II
Status Open, Classified
FEI number 3012642695

At a glance

  • None 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)