Device recall

Z-0543-2012: AGLH - Lung Health Study, Saliva & Finger Stick Supplemental Kit, Product A2352…

FDA device recall · Class II · Heritage Labs International LLC

Key facts

Recall number (Z-number) Z-0543-2012
Recall event 57863
Product AGLH - Lung Health Study, Saliva & Finger Stick Supplemental Kit, Product A2352, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, and subassembly collection packs (finger stick kit and saliva kit). Blood specimen collection
Product code KDT
Recalling firm Heritage Labs International LLC
Recall class Class II
Status Terminated
Termination date Dec 26, 2012
FEI number 1000118383

At a glance

  • None Linked 510(k)s
  • 10–99 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)