Device recall

Z-2730-2017: Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used…

FDA device recall · Class II · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-2730-2017
Recall event 77364
Product Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
Product code JIX
Recalling firm Beckman Coulter Inc
Recall class Class II
Status Terminated
Termination date Sep 9, 2020
510(k) numbers K071277
FEI number 2050012

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)