Device recall

Z-0865-2010: i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer

FDA device recall · Class II · Abbott Point of Care Inc.

Key facts

Recall number (Z-number) Z-0865-2010
Recall event 53483
Product i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
Product code JQP
Recalling firm Abbott Point of Care Inc.
Recall class Class II
Status Terminated
Termination date Jul 1, 2010
510(k) numbers K001387
FEI number 2245578

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

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