Device recall

Z-2088-2014: Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro…

FDA device recall · Class II · ITC-Nexus Dx

Key facts

Recall number (Z-number) Z-2088-2014
Recall event 68659
Product Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Product code JPA
Recalling firm ITC-Nexus Dx
Recall class Class II
Status Terminated
Termination date Dec 11, 2014
510(k) numbers K940401
FEI number 2250033

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)