Device recall

Z-0379-2017: ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the…

FDA device recall · Class II · Abbott Laboratories

Key facts

Recall number (Z-number) Z-0379-2017
Recall event 75448
Product ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
Product code KHP
Recalling firm Abbott Laboratories
Recall class Class II
Status Terminated
Termination date May 17, 2017
FEI number 1415939

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)