Device recall

Z-2814-2015: Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number…

FDA device recall · Class II · Siemens Healthcare Diagnostics Inc

Key facts

Recall number (Z-number) Z-2814-2015
Recall event 72044
Product Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin…
Product code KHP
Recalling firm Siemens Healthcare Diagnostics Inc
Recall class Class II
Status Terminated
Termination date May 23, 2016
510(k) numbers K113216
FEI number 3002637618

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)